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Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): additional results from the Monthly Oral Therapy With Ibandronate For Osteoporosis Intervention (MOTION) study.
Clin Ther. 2009 Apr; 31(4):751-61.CT

Abstract

BACKGROUND

The MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis Intervention) study reported that once-monthly ibandronate was noninferior to once-weekly alendronate in terms of increasing bone mineral density (BMD) at the lumbar spine and total hip over 12 months. On analysis of secondary and exploratory end points in MOTION, which included trochanter and femoral neck BMD, monthly ibandronate was found to be noninferior to weekly alendronate. The coprimary, secondary, and exploratory BMD end points from MOTION have been previously reported.

OBJECTIVE

This report presents additional results from the MOTION study, including response rates in terms of lumbar spine and total hip BMD gains above baseline; findings from a comparison of serum concentrations of bone turnover markers; and tolerability analysis, including adverse events that led to withdrawal and gastrointestinal (GI) adverse events.

METHODS

MOTION was a 12-month (with 15-day follow-up), randomized, multinational, multicenter, double-blind, double-dummy, parallel-group, noninferiority study in postmenopausal women aged 55 to <85 years with osteoporosis. Patients were randomly assigned to receive 150-mg-monthly oral ibandronate and weekly alendronate-matched placebo, or 70-mg-weekly oral alendronate and monthly ibandronate-matched placebo, for 12 months. At baseline, day 7 of treatment, 3 and 6 months, 6 months + 7 days, and 12 months, serum concentrations of markers of bone resorption (C-telopeptide of the a chain of type 1 collagen [sCTX]) and bone formation (serum N-terminal propeptides of type 1 collagen) were measured in a subset of the total trial population. At baseline and month 12, BMD was measured using dual-energy x-ray absorptiometry. Exploratory analyses of patients whose spine, total hip, and trochanter BMD at 12 months were above baseline (responders) were also performed.

RESULTS

A total of 1760 women were enrolled (ibandronate, 887 patients; alendronate, 873). The median changes in the trough concentrations of sCTX were -75.5% with monthly ibandronate and -81.2% with weekly alendronate. The percentage of patients with mean lumbar spine and total hip BMD gains above baseline (responders) were 90% and 87%, respectively, for ibandronate and 92% and 90%, respectively, for alendronate. GI adverse events were reported in <or=30% of patients per group during this 1-year study.

CONCLUSION

The data from these postmenopausal women with osteoporosis suggest that once-monthly 150-mg ibandronate therapy provided clinically comparable efficacy in terms of BMD response, reductions in bone turnover, and GI tolerability similar to that of weekly 70-mg alendronate.

Authors+Show Affiliations

Radiant Research, Wyomissing, Pennsylvania 19610, USA. bonedocron@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19446148

Citation

Emkey, Ronald, et al. "Efficacy and Tolerability of Once-monthly Oral Ibandronate (150 Mg) and Once-weekly Oral Alendronate (70 Mg): Additional Results From the Monthly Oral Therapy With Ibandronate for Osteoporosis Intervention (MOTION) Study." Clinical Therapeutics, vol. 31, no. 4, 2009, pp. 751-61.
Emkey R, Delmas PD, Bolognese M, et al. Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): additional results from the Monthly Oral Therapy With Ibandronate For Osteoporosis Intervention (MOTION) study. Clin Ther. 2009;31(4):751-61.
Emkey, R., Delmas, P. D., Bolognese, M., Borges, J. L., Cosman, F., Ragi-Eis, S., Recknor, C., Zerbini, C. A., Neate, C., Sedarati, F., & Epstein, S. (2009). Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): additional results from the Monthly Oral Therapy With Ibandronate For Osteoporosis Intervention (MOTION) study. Clinical Therapeutics, 31(4), 751-61. https://doi.org/10.1016/j.clinthera.2009.04.018
Emkey R, et al. Efficacy and Tolerability of Once-monthly Oral Ibandronate (150 Mg) and Once-weekly Oral Alendronate (70 Mg): Additional Results From the Monthly Oral Therapy With Ibandronate for Osteoporosis Intervention (MOTION) Study. Clin Ther. 2009;31(4):751-61. PubMed PMID: 19446148.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): additional results from the Monthly Oral Therapy With Ibandronate For Osteoporosis Intervention (MOTION) study. AU - Emkey,Ronald, AU - Delmas,Pierre D, AU - Bolognese,Michael, AU - Borges,Joao Lindolfo C, AU - Cosman,Felicia, AU - Ragi-Eis,Sergio, AU - Recknor,Christopher, AU - Zerbini,Cristiano A, AU - Neate,Colin, AU - Sedarati,Farhad, AU - Epstein,Solomon, PY - 2009/03/10/accepted PY - 2009/5/19/entrez PY - 2009/5/19/pubmed PY - 2009/7/28/medline SP - 751 EP - 61 JF - Clinical therapeutics JO - Clin Ther VL - 31 IS - 4 N2 - BACKGROUND: The MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis Intervention) study reported that once-monthly ibandronate was noninferior to once-weekly alendronate in terms of increasing bone mineral density (BMD) at the lumbar spine and total hip over 12 months. On analysis of secondary and exploratory end points in MOTION, which included trochanter and femoral neck BMD, monthly ibandronate was found to be noninferior to weekly alendronate. The coprimary, secondary, and exploratory BMD end points from MOTION have been previously reported. OBJECTIVE: This report presents additional results from the MOTION study, including response rates in terms of lumbar spine and total hip BMD gains above baseline; findings from a comparison of serum concentrations of bone turnover markers; and tolerability analysis, including adverse events that led to withdrawal and gastrointestinal (GI) adverse events. METHODS: MOTION was a 12-month (with 15-day follow-up), randomized, multinational, multicenter, double-blind, double-dummy, parallel-group, noninferiority study in postmenopausal women aged 55 to <85 years with osteoporosis. Patients were randomly assigned to receive 150-mg-monthly oral ibandronate and weekly alendronate-matched placebo, or 70-mg-weekly oral alendronate and monthly ibandronate-matched placebo, for 12 months. At baseline, day 7 of treatment, 3 and 6 months, 6 months + 7 days, and 12 months, serum concentrations of markers of bone resorption (C-telopeptide of the a chain of type 1 collagen [sCTX]) and bone formation (serum N-terminal propeptides of type 1 collagen) were measured in a subset of the total trial population. At baseline and month 12, BMD was measured using dual-energy x-ray absorptiometry. Exploratory analyses of patients whose spine, total hip, and trochanter BMD at 12 months were above baseline (responders) were also performed. RESULTS: A total of 1760 women were enrolled (ibandronate, 887 patients; alendronate, 873). The median changes in the trough concentrations of sCTX were -75.5% with monthly ibandronate and -81.2% with weekly alendronate. The percentage of patients with mean lumbar spine and total hip BMD gains above baseline (responders) were 90% and 87%, respectively, for ibandronate and 92% and 90%, respectively, for alendronate. GI adverse events were reported in <or=30% of patients per group during this 1-year study. CONCLUSION: The data from these postmenopausal women with osteoporosis suggest that once-monthly 150-mg ibandronate therapy provided clinically comparable efficacy in terms of BMD response, reductions in bone turnover, and GI tolerability similar to that of weekly 70-mg alendronate. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/19446148/Efficacy_and_tolerability_of_once_monthly_oral_ibandronate__150_mg__and_once_weekly_oral_alendronate__70_mg_:_additional_results_from_the_Monthly_Oral_Therapy_With_Ibandronate_For_Osteoporosis_Intervention__MOTION__study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(09)00127-1 DB - PRIME DP - Unbound Medicine ER -