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

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

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Osteoporosis
• Intervention / Treatment: Drug: Alendronate; Dietary supplement: Elemental Calcium; Dietary supplement: Vitamin D; Drug: Risendronate placebo; Drug: Risedronate 35 mg; Drug: Alendronate placebo

• Study Type: Interventional
• Enrollment (Actual): 1053
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alendronate 70 mg; Alendronate sodium, 70 mg, orally once weekly for up to 24 months	Drug: Alendronate; Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.; Other Names: FOSAMAX®; MK-0217; 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.; Dietary supplement: 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.
Active Comparator: Risendronate 35 mg; Risendronate, 35 mg, orally once weekly for up to 24 months	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.; Dietary supplement: 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: Risedronate 35 mg; Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.; Other Names: Actonel®; Atelvia®; Drug: Alendronate placebo; Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months	Baseline and 12 months
Mean percent change from baseline in hip trochanter BMD at 24 months	Baseline and 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Organon and Co
• Investigators: Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2002
• Primary Completion (Actual): April 1, 2004
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: September 21, 2004
• First Submitted That Met QC Criteria: September 23, 2004
• First Posted (Estimated): September 24, 2004

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Vitamin D; Calcium; Alendronate; Risedronic Acid
• Other Study ID Numbers: 0217-211; 2004_016 (Other Identifier: Protocol number)

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis