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Monthly ibandronate suppresses serum CTX-I within 3 days and maintains a monthly fluctuating pattern of suppression
N Binkley1, S L Silverman, C Simonelli
1Osteoporosis Clinical Center and Research Program, University of Wisconsin, 2870 University Avenue, Suite 100, Madison, WI 53705, USA. nbinkley@wisc.edu
Insights
Monthly ibandronate rapidly suppresses bone turnover marker CTX-I within 3 days in postmenopausal osteoporosis patients. Levels remained suppressed for 6 months, demonstrating ibandronate
Area of Science:
- Endocrinology and Metabolism
- Bone Biology and Osteoporosis
- Pharmacology and Drug Efficacy
Background:
- Postmenopausal osteoporosis (PMO) is a significant health concern.
- Assessing drug efficacy in PMO requires monitoring bone turnover markers.
- Serum C-terminal cross-linking telopeptide of type I collagen (CTX-I) is a key marker for bone resorption.
Purpose of the Study:
- To evaluate the speed and pattern of serum CTX-I suppression with once-monthly oral ibandronate in women with PMO.
- To assess the efficacy of ibandronate in reducing bone resorption markers.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 67 women with PMO.
- Participants received either once-monthly oral ibandronate (150 mg) or placebo for 6 months.
- Serum CTX-I levels were measured at baseline and at multiple time points post-dose over 6 months.
Main Results:
- Ibandronate demonstrated a rapid reduction in serum CTX-I, with a median decrease of 70.2% from baseline by day 3.
- Serum CTX-I levels remained consistently suppressed below baseline throughout the 6-month study period in the ibandronate group.
- A regular monthly fluctuation in CTX-I levels was observed, correlating with the dosing schedule.
Conclusions:
- Once-monthly oral ibandronate effectively and rapidly suppresses the bone resorption marker CTX-I within 3 days.
- Sustained suppression of CTX-I below baseline levels was maintained for 6 months.
- Ibandronate was well-tolerated and showed a consistent pattern of efficacy in this patient population.
Unlabelled:
Bone turnover markers such as serum C-terminal cross-linking telopeptide of type I collagen (CTX-I) can be used to assess drug efficacy in osteoporosis. This study evaluated the pattern of CTX-I suppression in postmenopausal osteoporotic women receiving ibandronate. Ibandronate decreased serum CTX-I levels within 3 days of therapy initiation. Over 6 months, the levels remained suppressed below baseline.
Introduction:
This randomized, double-blind, placebo-controlled study evaluated the rapidity of onset and pattern of suppression of the bone resorption marker serum CTX-I in women with postmenopausal osteoporosis (PMO) who received once-monthly oral ibandronate.
Methods:
Women diagnosed with PMO received once-monthly oral ibandronate (150 mg) or placebo for 6 months. Serum CTX-I was measured at baseline and after study dose administration on day 3 (month 1 only) and days 7, 14, 21, and 28 (months 1-6). Bone-specific alkaline phosphatase was measured on days 7 and 28 (months 1-6).
Results:
This study enrolled 67 women: 49 received ibandronate, 17 received placebo, and one took no study drug. At day 3, median reduction in serum CTX-I from baseline was 70.2% with ibandronate and 6.0% with placebo (difference, -64.2%; 95% confidence interval, -80.3% to -46.2%; p < 0.0001). In women receiving ibandronate, serum CTX-I levels remained consistently below baseline, exhibiting a regular monthly fluctuating pattern of suppression over 6 months. Ibandronate was well-tolerated.
Conclusions:
Monthly ibandronate decreased serum CTX-I within 3 days. Over 6 months, in women receiving once-monthly ibandronate, serum CTX-I remained suppressed below baseline. A monthly fluctuation, related to time from last dose, was observed.
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