THOUSAND OAKS, Calif.,
Sept. 7, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that it will present
data from multiple studies for its investigational agent
romosozumab and for Prolia® (denosumab) at the Annual
Meeting of the American Society for Bone and Mineral Research
(ASBMR) in Atlanta on Sept. 16-19, 2016. At the congress, Amgen will
highlight a diverse set of data across its osteoporosis clinical
programs, as well as real-world data that provide important
insights on living with osteoporosis and underscore the Company's
commitment to pioneering novel treatment options that can help
reduce fracture risk.
"As a leader in bone biology, Amgen is committed to translating
innovative science into treatments that make a difference in the
lives of people," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "The breadth and depth of clinical and
real-world data we're presenting at ASBMR demonstrates our
commitment to finding potential options for patients with
osteoporosis. We look forward to sharing detailed data from our
Phase 3 FRAME study of romosozumab, along with new clinical data
and real-world research on Prolia."
The romosozumab FRAME abstract, "Fracture Risk Reduction With
Romosozumab: Results of the Phase 3 FRAME Study (FRActure
study in postmenopausal woMen with ostEoporosis),"
has been awarded the 2016 ASBMR Most Outstanding Clinical Abstract
Award, which is given to the lead investigator of the highest
ranking abstract submitted to a clinical category for presentation
at the ASBMR Annual Meeting. Lead author Dr. Felicia Cosman, medical director of the Clinical
Research Center at Helen Hayes Hospital, professor of Medicine at
Columbia University College of Physicians and
Surgeons in New York, will
be presented with the award on Sunday, Sept.
18.
Prolia presentations will include additional analyses from the
three-year FREEDOM trial and its seven-year extension, further
characterizing the long-term (up to 10 years) efficacy and safety
of Prolia in postmenopausal women with osteoporosis, as well as
real-world data showing long-term (two-year) persistence rates for
Prolia and other osteoporosis therapies among postmenopausal
women.
Osteoporosis disease-state study presentations will provide key
insights on unmet needs among patients at high risk for
fracture.
Romosozumab is being co-developed
by Amgen and UCB.
SELECTED ABSTRACTS OF INTEREST
Romosozumab Oral Presentation
- Fracture Risk Reduction With Romosozumab: Results of the
Phase 3 FRAME Study (FRActure study in postmenopausal woMen with
ostEoporosis)
Abstract 1096, Oral Presentation, Sunday,
Sept. 18, 9:45 a.m.-10 a.m. ET
(Sidney Marcus Auditorium – Building A)
Romosozumab Pre-clinical Oral Presentation
- Effects of Romosozumab on Remodeling and Bone Strength at
the Distal Radius in Ovariectomized Cynomolgus
Monkeys
Abstract 1024, Oral Presentation, Friday, Sept. 16, 3:45
p.m.-4 p.m. ET (Room A411/412)
Romosozumab Abstract of Interest
- Romosozumab Blocks the Binding of Sclerostin to the Two Key
Wnt Signaling Co-receptors, LRP5 and LRP6, but not to
LRP4
Abstract MO0300, Poster Presentation, Monday, Sept. 19, 12:30
p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
Prolia Late-Breaking Abstract of Interest
- Effects of Up to 10 Years of Denosumab Treatment on Bone
Matrix Mineralization: Results From the FREEDOM
Extension
Abstract LB-1163, Late-Breaking Oral Presentation,
Monday, Sept. 19, 11:48 a.m.-noon ET (Room A404/405)
Prolia Oral Presentations
- Effect of 10 Years of Denosumab Treatment on Bone Histology
and Histomorphometry in the FREEDOM Extension Study
Abstract
1005, Oral Presentation, Friday, Sept.
16, 1:45 p.m.-2 p.m. ET
(Sidney Marcus Auditorium – Building A)
- Discontinuation of Denosumab and Associated Fracture
Incidence: Analysis From FREEDOM and its Extension
Abstract
1100, Oral Presentation, Sunday, Sept.
18, 10:45 a.m.-11 a.m. ET
(Sidney Marcus Auditorium – Building A)
Prolia Abstracts of Interest
- The Risk of Subsequent Osteoporotic Fractures Is Decreased
in Patients Experiencing Fracture While on Denosumab: Results From
the FREEDOM and FREEDOM Extension Studies
Abstract FR0288
and SA0288, Plenary Poster, Friday, Sept.
16, 5:30 p.m.-7 p.m. ET and
Saturday, Sept. 17, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall –
Expo Hall A1)
- Denosumab Treatment for 10 Years in Postmenopausal Women
With Osteoporosis Was Associated With Substantially Lower Fracture
Incidence Relative to Their Baseline FRAX-Predicted
Probability
Abstract FR0289 and SA0289, Plenary Poster, Friday, Sept. 16, 5:30
p.m.-7 p.m. ET and Saturday, Sept.
17, 12:30 p.m.-2:30 p.m. ET
(ASBMR Discovery Hall – Expo Hall A1)
- Fracture Risk After
Discontinuation of Denosumab
Abstract FR0294 and SA0294, Plenary Poster, Friday, Sept. 16, 5:30
p.m.-7 p.m. ET and Saturday, Sept.
17, 12:30 p.m.-2:30 p.m. ET
(ASBMR Discovery Hall – Expo Hall A1)
- Bone Microarchitecture After Discontinuation of Denosumab in
Postmenopausal Women With Low Bone Mass
Abstract SU0285, Poster Presentation, Sunday, Sept. 18, 12:30
p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
- Denosumab (DMAb) and Total Lean Body Mass: Exploratory
Analyses from the FREEDOM Study
Abstract SU0286, Poster Presentation, Sunday, Sept. 18, 12:30
p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
- Persistence with Osteoporosis Therapies in Postmenopausal
Women in a Large US National Health Plan
Abstract SU0296, Poster Presentation, Sunday, Sept. 18, 12:30
p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
- Long-Term Persistence with Osteoporosis Therapies Among
Postmenopausal Women in a Commercially-Insured Population in
the United States
Abstract SU0293, Poster Presentation, Sunday, Sept. 18, 12:30
p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
Osteoporosis Disease State Abstracts of Interest
- Estimating the Long-Term Functional Burden of
Osteoporosis-Related Fractures
Abstract MO0243, Poster
Presentation, Monday, Sept. 19,
12:30 p.m.-2:30 p.m. ET (ASBMR
Discovery Hall – Expo Hall A1)
- High Risk of Second Fracture Within 1, 2, 5 Years After
Prior Fracture Among Women 65 years or Older
Abstract
FR0233 and SA0233, Plenary Poster, Friday,
Sept. 16, 5:30 p.m.-7 p.m. ET
and Saturday, Sept. 17, 12:30 p.m.-2:30 p.m. ET (Room ASBMR Discovery
Hall – Expo Hall A1)
- Prediction of Two-Year Risk of Fracture Among Older US
Women
Abstract FR0237 and SA0237, Plenary Poster,
Friday, Sept. 16, 5:30 p.m.-7 p.m. ET and Saturday, Sept. 17, 12:30
p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
- Predictors of Imminent Fracture Risk in Medicare-Enrolled
Men and Women
Abstract SU0227, Poster Presentation,
Sunday, Sept. 18, 12:30 p.m.-2:30 p.m. ET (ASBMR Discovery Hall –
Expo Hall A1)
- Predictors of Imminent Risk of Non-Vertebral Fracture in
Older Women: The Framingham Osteoporosis Study
Abstract
MO0232, Poster Presentation, Monday, Sept.
19, 12:30 p.m.-2:30 p.m. ET
(ASBMR Discovery Hall – Expo Hall A1)
- Characteristics of Patients at High One-Year Fracture
Risk
Abstract MO0223, Poster Presentation, Monday, Sept. 19, 12:30
p.m.-2:30 p.m. ET (ASBMR Discovery Hall – Expo Hall A1)
Amgen Webcast Investor Call
Amgen will host a webcast
call for the investment community on Monday,
Sept. 19, 2016, at 11:30 a.m.
ET. Sean E. Harper,
M.D., executive vice president of Research and Development at
Amgen, M.D., along with members of Amgen's clinical development
team and clinical investigators, will participate in the call to
discuss Amgen's clinical data presented at ASBMR, including the
romosozumab Phase 3 study (FRAME).
Live audio of the investor call will be simultaneously broadcast
over the Internet and will be available to members of the news
media, investors and the general public.
The webcast, as with other selected presentations regarding
developments in Amgen's business given by management at certain
investor and medical conferences, can be found on Amgen's website,
www.amgen.com, under Investors. Information regarding presentation
times, webcast availability and webcast links are noted on Amgen's
Investor Relations Events Calendar. The webcast will be archived
and available for replay for at least 90 days after the
event.
About Osteoporosis
Osteoporosis affects many women
after menopause as their ability to form new bone cannot counter
balance the rate at which bone is being removed.1,2 This
bone loss leads to weakened bones over time, increasing the
potential for a break.3
It is estimated that one in three women over the age of 50 will
experience an osteoporotic fracture.4,5 Patients who
experience an osteoporosis-related fracture are twice as likely to
experience a future fracture.6
The World Health Organization has officially declared
osteoporosis a public health crisis,7,8 and the
International Osteoporosis Foundation urges governments worldwide
to make osteoporosis a healthcare priority.9
About Prolia®
(denosumab)
Prolia® is indicated for the
treatment of postmenopausal women with osteoporosis at high risk
for fracture, defined as a history of osteoporotic fracture, or
multiple risk factors for fracture; or patients who have failed or
are intolerant to other available osteoporosis therapy. In
postmenopausal women with osteoporosis, Prolia reduces the
incidence of vertebral, nonvertebral, and hip fractures.
Prolia is indicated for treatment to increase bone mass in men
with osteoporosis at high risk for fracture, defined as a history
of osteoporotic fracture, or multiple risk factors for fracture; or
patients who have failed or are intolerant to other available
osteoporosis therapy.
Prolia is indicated as a treatment to increase bone mass in men
at high risk for fracture receiving androgen deprivation therapy
for nonmetastatic prostate cancer. In these patients Prolia also
reduced the incidence of vertebral fractures.
Prolia is indicated as a treatment to increase bone mass in
women at high risk for fracture receiving adjuvant aromatase
inhibitor therapy for breast cancer.
Important Safety Information (U.S.)
Contraindications
Prolia® is contraindicated in patients with
hypocalcemia. Pre‐existing hypocalcemia must be corrected prior to
initiating Prolia®. Prolia® is
contraindicated in women who are pregnant and may cause fetal harm.
Prolia® is contraindicated in patients with a history of
systemic hypersensitivity to any component of the product.
Reactions have included anaphylaxis, facial swelling and
urticaria.
Same Active Ingredient
Prolia® contains the
same active ingredient (denosumab) found in XGEVA®.
Patients receiving Prolia® should not receive
XGEVA®.
Hypersensitivity
Clinically significant
hypersensitivity including anaphylaxis has been reported with
Prolia®. Symptoms have included hypotension, dyspnea,
throat tightness, facial and upper airway edema, pruritus, and
urticaria. If an anaphylactic or other clinically significant
allergic reaction occurs, initiate appropriate therapy and
discontinue further use of Prolia®.
Hypocalcemia
Hypocalcemia may worsen with the use of
Prolia®, especially in patients with severe renal
impairment. In patients predisposed to hypocalcemia and
disturbances of mineral metabolism, clinical monitoring of calcium
and mineral levels is highly recommended within 14 days of
Prolia® injection. Adequately supplement all patients
with calcium and vitamin D.
Osteonecrosis of the Jaw (ONJ)
ONJ, which can occur
spontaneously, is generally associated with tooth extraction and/or
local infection with delayed healing, and has been reported in
patients receiving Prolia®. An oral exam should be
performed by the prescriber prior to initiation of
Prolia®. A dental examination with appropriate
preventive dentistry is recommended prior to treatment in patients
with risk factors for ONJ such as invasive dental procedures,
diagnosis of cancer, concomitant therapies (e.g., chemotherapy,
corticosteroids, angiogenesis inhibitors), poor oral hygiene, and
co‐morbid disorders. Good oral hygiene practices should be
maintained during treatment with Prolia®. The risk of
ONJ may increase with duration of exposure to
Prolia®.
For patients requiring invasive dental procedures, clinical
judgment should guide the management plan of each patient. Patients
who are suspected of having or who develop ONJ should receive care
by a dentist or an oral surgeon. Extensive dental surgery to treat
ONJ may exacerbate the condition. Discontinuation of
Prolia® should be considered based on individual
benefit‐risk assessment.
Atypical Femoral Fractures
Atypical low-energy, or low
trauma fractures of the shaft have been reported in patients
receiving Prolia®. Causality has not been established as
these fractures also occur in osteoporotic patients who have not
been treated with anti-resorptive agents.
During Prolia® treatment, patients should be advised
to report new or unusual thigh, hip, or groin pain. Any patient who
presents with thigh or groin pain should be evaluated to rule out
an incomplete femur fracture. Interruption of Prolia®
therapy should be considered, pending a risk/benefit assessment, on
an individual basis.
Serious Infections
In a clinical trial (N= 7808) in
women with postmenopausal osteoporosis, serious infections leading
to hospitalization were reported more frequently in the
Prolia® group than in the placebo group. Serious skin
infections, as well as infections of the abdomen, urinary tract and
ear were more frequent in patients treated with
Prolia®.
Endocarditis was also reported more frequently in
Prolia®-treated patients. The incidence of opportunistic
infections and the overall incidence of infections were similar
between the treatment groups. Advise patients to seek prompt
medical attention if they develop signs or symptoms of severe
infection, including cellulitis.
Patients on concomitant immunosuppressant agents or with
impaired immune systems may be at increased risk for serious
infections. In patients who develop serious infections while on
Prolia®, prescribers should assess the need for
continued Prolia® therapy.
Dermatologic Adverse Reactions
In the same clinical
trial in women with postmenopausal osteoporosis, epidermal and
dermal adverse events such as dermatitis, eczema and rashes
occurred at a significantly higher rate with Prolia®
compared to placebo. Most of these events were not specific to the
injection site. Consider discontinuing Prolia® if severe
symptoms develop.
Musculoskeletal Pain
Severe and occasionally
incapacitating bone, joint, and/or muscle pain has been reported in
patients taking Prolia®. Consider discontinuing use if
severe symptoms develop.
Suppression of Bone Turnover
In clinical trials in
women with postmenopausal osteoporosis, Prolia® resulted
in significant suppression of bone remodeling as evidenced by
markers of bone turnover and bone histomorphometry. The
significance of these findings and the effect of long-term
treatment are unknown. Monitor patients for these consequences,
including ONJ, atypical fractures, and delayed fracture
healing.
Adverse Reactions
The most common adverse reactions
(>5% and more common than placebo) in women with postmenopausal
osteoporosis are back pain, pain in extremity, musculoskeletal
pain, hypercholesterolemia, and cystitis. The most common adverse
reactions (> 5% and more common than placebo) in men with
osteoporosis are back pain, arthralgia, and nasopharyngitis.
Pancreatitis has been reported with Prolia®.
In women with postmenopausal osteoporosis, the overall incidence
of new malignancies was 4.3% in the placebo group and 4.8% in the
Prolia® group. In men with osteoporosis, new
malignancies were reported in no patients in the placebo group and
4 (3.3%) patients in the Prolia® group. A causal
relationship to drug exposure has not been established.
The most common (per patient incidence ≥ 10%) adverse reactions
reported with Prolia® in patients with bone loss
receiving ADT for prostate cancer or adjuvant AI therapy for breast
cancer are arthralgia and back pain. Pain in extremity and
musculoskeletal pain have also been reported in clinical trials.
Additionally, in Prolia®‐treated men with nonmetastatic
prostate cancer receiving ADT, a greater incidence of cataracts was
observed.
Denosumab is a human monoclonal antibody. As with all
therapeutic proteins, there is potential for immunogenicity.
Prolia® Postmarketing Active Safety Surveillance
Program
The surveillance program is available to collect
information from prescribers on specific adverse events. Please see
www.proliasafety.com or call 1‐800‐772‐6436 for more
information.
For more information, please see the Prolia Important Safety
Information, Prescribing Information, and Medication Guide.
About Romosozumab
Romosozumab is an investigational
bone-forming agent and is not approved by any regulatory authority
for the treatment of osteoporosis. It is designed to work by
inhibiting the protein sclerostin, and has a dual effect on bone,
both increasing bone formation and decreasing bone breakdown.
Romosozumab is being studied for its potential to reduce the risk
of fractures in an extensive global Phase 3 program. This program
includes two large fracture trials comparing romosozumab to either
placebo or active comparator in more than 10,000 postmenopausal
women with osteoporosis. Amgen and UCB are co-developing
romosozumab.
About the Amgen and UCB Collaboration
Since 2004,
Amgen and UCB have been working together under a collaboration and
license agreement to research, develop and market antibody products
targeting the sclerostin protein. As part of this agreement, the
two companies continue to collaborate on the development of
romosozumab for the treatment of osteoporosis. This gene-to-drug
project demonstrates how Amgen and UCB are joining forces to turn
genetic discoveries into new medicine, turning conceptual science
into a reality. If approved, Amgen will lead romosozumab
commercialization in the United states, Canada, Mexico and Japan, and UCB will lead commercialization in
all EU member countries, as well as Switzerland, Norway, Australia and New
Zealand.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its biologics manufacturing expertise to strive for solutions that
improve health outcomes and dramatically improve people's lives. A
biotechnology pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or
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relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products after they are
on the market.
Our results may be affected by our ability to successfully
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current and future products, sales growth of recently launched
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Further, while we routinely obtain patents for our products and
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intellectual property litigation. We perform a substantial amount
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activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. In
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of new products. Further, some raw materials, medical devices and
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similar to one of our products that implicate an entire class of
products could have a material adverse effect on sales of the
affected products and on our business and results of operations.
Our efforts to acquire other companies or products and to integrate
the operations of companies we have acquired may not be successful.
We may not be able to access the capital and credit markets on
terms that are favorable to us, or at all. We are increasingly
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number of events. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration or European Commission, and no conclusions can or
should be drawn regarding the safety or effectiveness of the
product candidates. Further, the scientific information discussed
in this news release relating to new indications for our products
is preliminary and investigative and is not part of the labeling
approved by the U.S. Food and Drug Administration or the European
Medicines Agency for the products. The products are not approved
for the investigational use(s) discussed in this news release, and
no conclusions can or should be drawn regarding the safety or
effectiveness of the products for these uses.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
1 U.S. Department of Health and Human Services,
Office of the Surgeon General. The 2004 Surgeon General's Report on
Bone Health and Osteoporosis: What It Means to You.
http://www.ncbi.nlm.nih.gov/books/NBK45513/pdf/Bookshelf_NBK45513.pdf.
Published October 14, 2004. Accessed
February 2016.
2 Cosman F et al. Clinician's Guide to Prevention and
Treatment of Osteoporosis. Osteoporos Int. 2014; 25: 2359–2381.
3 International Osteoporosis Foundation. What Is
Osteoporosis? 2015. Available at:
http://www.iofbonehealth.org/what-is-osteoporosis. Accessed
February 2016.
4 International Osteoporosis Foundation. The Global
Burden of Osteoporosis. What you need to know. Available at:
http://www.iofbonehealth.org/data-publications/fact-sheets/what-you-need-know-about-osteoporosis.
Accessed February 2016.
5 International Osteoporosis Foundation. Osteoporosis in
the European Union in 2008: Ten years of progress and ongoing
challenges (October 2008). Available
at:
http://www.iofbonehealth.org/sites/default/files/PDFs/EU%20Reports/eu_report_2008.pdf.
Accessed February 2016.
6 International Osteoporosis Foundation. Stop at One.
One Fracture Leads to Another.
http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-patient_brochure.pdf.
Accessed February 2016.
7 International Osteoporosis Foundation. The National
Coalition for Osteoporosis and Related Bone Diseases Briefed
Congress on Action Plan for a National Vision for Bone Health.
Available at
http://www.prnewswire.com/news-releases/the-national-coalition-for-osteoporosis-and-related-bone-diseases-briefed-congress-on-action-plan-for-a-national-vision-for-bone-health-61945017.html.
Accessed September 2016.
8 The World Health Organization. Bulletin of the World
Health Organization. Exercise interventions: defusing the world's
osteoporosis time bomb. Available at:
http://www.who.int/bulletin/volumes/81/11/mingchanwa1103.pdf.
Accessed February 2016.
9 International Osteoporosis Foundation. Global
Initiatives. Available at
http://www.iofbonehealth.org/global-initiatives-0. Accessed
February 2016.
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