Efficacy of risedronate with cholecalciferol on 25-hydroxyvitamin D level and bone turnover in Korean patients with osteoporosis

Summary Background  We performed a randomized, double‐blind, prospective, 16‐week clinical trial to evaluate the efficacy and safety of risedronate with and without cholecalciferol on 25‐hydroxyvitamin D [25(OH)D] levels and bone markers in Korean patients with osteoporosis. Methods  We randomly ass...

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Published in:Clinical endocrinology (Oxford) 2011-06, Vol.74 (6), p.699-704
Main Authors: Chung, Ho-Yeon, Chin, Sang Ouk, Kang, Moo-IL, Koh, Jung-Min, Moon, Sung-Hwan, Yoon, Byung-Koo, Yoon, Hyun-Koo, Chung, Yoon-Sok, Park, Hyoung-Moo
Format: Article
Language:English
Subjects:
25-Hydroxyvitamin D
Aged
Alkaline phosphatase
Alkaline Phosphatase - blood
Asian Continental Ancestry Group
Biological and medical sciences
Bisphosphonates
Bone Density - drug effects
Bone Density Conservation Agents - adverse effects
Bone Density Conservation Agents - therapeutic use
Bone turnover
Cholecalciferol - adverse effects
Cholecalciferol - therapeutic use
Clinical trials
Collagen
Collagen Type I - blood
Diseases of the osteoarticular system
Double-Blind Method
Drug Therapy, Combination
Endocrinopathies
Etidronic Acid - adverse effects
Etidronic Acid - analogs & derivatives
Etidronic Acid - therapeutic use
Female
Fundamental and applied biological sciences. Psychology
Gastrointestinal Diseases - chemically induced
Humans
Korea
Male
Medical sciences
Middle Aged
Muscles
Osteoporosis
Osteoporosis - blood
Osteoporosis - drug therapy
Osteoporosis - ethnology
Osteoporosis, Postmenopausal - blood
Osteoporosis, Postmenopausal - drug therapy
Osteoporosis, Postmenopausal - ethnology
Osteoporosis. Osteomalacia. Paget disease
Parathyroid hormone
Parathyroid Hormone - blood
Peptides - blood
Prospective Studies
Radioimmunoassay
Risedronate Sodium
Risedronic acid
Serum levels
Treatment Outcome
Vertebrates: endocrinology
Vitamin D - analogs & derivatives
Vitamin D - blood
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Summary:Summary Background  We performed a randomized, double‐blind, prospective, 16‐week clinical trial to evaluate the efficacy and safety of risedronate with and without cholecalciferol on 25‐hydroxyvitamin D [25(OH)D] levels and bone markers in Korean patients with osteoporosis. Methods  We randomly assigned 164 adults with osteoporosis to one of two treatment groups: weekly risedronate 35 mg and cholecalciferol 5600 IU combined in a single pill (RSD+) or weekly risedronate 35 mg alone (RSD). We measured serum levels of 25(OH)D, parathyroid hormone (PTH), and bone markers and performed muscle function tests, at baseline and after 16 weeks of treatment. Results  After 16 weeks of treatment, mean serum 25(OH)D increased significantly from 39·8 to 70·8 nmol/l in the RSD+ group and declined significantly from 40·5 to 35 nmol/l in the RSD group. Although both treatment groups had significant increases in serum PTH over baseline during the study, the RSD group had a significantly larger increase than the RSD+ group (13·6 vs 4·8 ng/l; P = 0·0005). In both groups, serum bone‐specific alkaline phosphatase (BSAP) and C‐terminal telopeptide (CTX) declined rapidly; there were no significant differences between groups. There was also no significant difference between groups in lower‐extremity function tests. The overall incidence of clinical adverse events was not significantly different between groups. Conclusion  In patients with osteoporosis, a once‐weekly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D level over a 16‐week treatment period without significant adverse events.
ISSN:0300-0664
1365-2265
DOI:10.1111/j.1365-2265.2011.04041.x