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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A phase 3 trial of the efficacy and safety of oral recombinant calcitonin: The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) trial
Journal of Bone and Mineral Research, Volume 27, No. 8, Year 2012
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Description
The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis. A total of 565 women age 46 to 86 (mean 66.5) years were randomized (4:3:2) to receive oral recombinant salmon calcitonin (rsCT) tablets (0.2 mg/d) plus placebo nasal spray, synthetic salmon calcitonin (ssCT) nasal spray (200 IU/d) plus placebo tablets, or placebo (placebo tablets plus placebo nasal spray), respectively for 48 weeks. All women received calcium (≥1000 mg/d) and vitamin D (800 IU/d). Women randomized to oral rsCT had a mean ± SD percent increase from baseline in lumbar spine bone mineral density (BMD) (1.5% ± 3.2%) that was greater than those randomized to ssCT nasal spray (0.78% ± 2.9%) or placebo (0.5% ± 3.2%). Lumbar spine BMD change in those receiving nasal calcitonin did not differ from placebo. Oral rsCT treatment also resulted in greater improvements in trochanteric and total proximal femur BMD than ssCT nasal spray. Reductions in bone resorption markers with oral rsCT were greater than those observed in ssCT nasal spray or placebo recipients. Approximately 80% of subjects in each treatment group experienced an adverse event, the majority of which were mild or moderate in intensity. Gastrointestinal system adverse events were reported by nearly one-half of women in all treatment groups and were the principal reason for premature withdrawals. Less than 10% of women experienced a serious adverse event and no deaths occurred. Overall, oral rsCT was superior to nasal ssCT and placebo for increasing BMD and reducing bone turnover. Oral rsCT was safe and as well tolerated as ssCT nasal spray or placebo. Oral calcitonin may provide an additional treatment alternative for women with postmenopausal osteoporosis. Copyright © 2012 American Society for Bone and Mineral Research.
Authors & Co-Authors
Binkley, N.
United States, Madison
University of Wisconsin-madison
Bolognese, Michael A.
United States, Bethesda
Bethesda
Sidorowicz-Białynicka, Anna
Poland, Wroclaw
Hak Sp. z O.o.
Vally, Tasneem
South Africa, Pretoria
Synexus Watermeyer Clinical Research Centre
Trout, Richard
United States, New Brunswick
Rutgers University–new Brunswick
Miller, Colin
United States, Princeton
Bioclinica, Inc.
Buben, Christine E.
United States, Philadelphia
Tarsa Therapeutics Inc
Gilligan, James P.
United States, Philadelphia
Tarsa Therapeutics Inc
Krause, David S.
United States, Philadelphia
Tarsa Therapeutics Inc
Statistics
Citations: 9
Authors: 9
Affiliations: 7
Identifiers
Doi:
10.1002/jbmr.1602
ISSN:
08840431
e-ISSN:
15234681
Research Areas
Disability
Health System And Policy
Maternal And Child Health
Noncommunicable Diseases
Participants Gender
Female