A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)

Postmenopausal Osteoporosis Clinical Trial

— FACT  

Official title:

A 12-Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Once Weekly Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092014
• Other study ID #: 0217-211
• Secondary ID: 2004_016
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2002
• Est. completion date: April 1, 2004

Study information

• Verified date: April 2024
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1053
• Est. completion date: April 1, 2004
• Est. primary completion date: April 1, 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• Women with postmenopausal osteoporosis

Exclusion Criteria:

• Bilateral hip replacements

• Esophageal abnormalities

• Metabolic bone disease (example - Vitamin D deficiency)

• Medications that would affect the breakdown or build-up of bone turnover

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Alendronate
Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
• Risedronate 35 mg
Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Dietary Supplement:
• Elemental Calcium
Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
• Vitamin D
Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.

Drug:
• Risendronate placebo
Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
• Alendronate placebo
Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (4)

Bonnick S, Saag KG, Kiel DP, McClung M, Hochberg M, Burnett SM, Sebba A, Kagan R, Chen E, Thompson DE, de Papp AE. Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. J Clin Endocrinol Metab. 2006 Jul;91(7):2631-7. doi: 10.1210/jc.2005-2602. Epub 2006 Apr 24. Erratum In: J Clin Endocrinol Metab. 2007 Aug;92(8):3032. — View Citation

Burnett-Bowie SM, Saag K, Sebba A, de Papp AE, Chen E, Rosenberg E, Greenspan SL. Prediction of changes in bone mineral density in postmenopausal women treated with once-weekly bisphosphonates. J Clin Endocrinol Metab. 2009 Apr;94(4):1097-103. doi: 10.1210/jc.2008-1122. Epub 2009 Jan 13. — View Citation

Rosen CJ, Hochberg MC, Bonnick SL, McClung M, Miller P, Broy S, Kagan R, Chen E, Petruschke RA, Thompson DE, de Papp AE; Fosamax Actonel Comparison Trial Investigators. Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study. J Bone Miner Res. 2005 Jan;20(1):141-51. doi: 10.1359/JBMR.040920. Epub 2004 Sep 29. — View Citation

Sebba AI, Bonnick SL, Kagan R, Thompson DE, Skalky CS, Chen E, de Papp AE; Fosamax Actonel Comparison Trial investigators. Response to therapy with once-weekly alendronate 70 mg compared to once-weekly risedronate 35 mg in the treatment of postmenopausal osteoporosis. Curr Med Res Opin. 2004 Dec;20(12):2031-41. doi: 10.1185/030079904x16768. Erratum In: Curr Med Res Opin. 2005 Feb;21(2):325. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months		Baseline and 12 months
Primary	Mean percent change from baseline in hip trochanter BMD at 24 months		Baseline and 24 months
Secondary	Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months		Baseline and 12 months
Secondary	Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months		Baseline and 24 months
Secondary	Change from baseline in biochemical markers of bone turnover at 12 months		Baseline and 12 months
Secondary	Change from baseline in biochemical markers of bone turnover at 24 months		Baseline and 24 months
Secondary	Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months		12 months
Secondary	Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months		24 months
Secondary	Number of participants who experienced one or more adverse events (AE)		Up to 24 months
Secondary	Number of participants who discontinued study medication due to an AE		Up to 24 months