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NCT00092027 Clinical Trial

A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)

Postmenopausal Osteoporosis Clinical Trial

Official title:
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for the Treatment of Osteoporosis in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092027
Other study ID # 0217-219
Secondary ID MK0217-2192004_0
Status Completed
Phase Phase 3
First received
Last updated
Start date March 19, 2003
Est. completion date March 15, 2004

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.

Recruitment information / eligibility
Status Completed
Enrollment 454
Est. completion date March 15, 2004
Est. primary completion date March 15, 2004
Accepts healthy volunteers No
Gender Female
Age group 25 Years and older
Eligibility Inclusion Criteria: - Women with postmenopausal osteoporosis Exclusion Criteria: - High risk for fractures - Esophageal abnormalities - Upper gastrointestinal symptoms that are not relieved with medication - Metabolic bone disease (example - vitamin D deficiency) - Medications that would affect the breakdown or build-up of bone

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0217, alendronate sodium/Duration of Treatment: 6 months

• Comparator: placebo / Duration of Treatment: 6 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Cryer B, Binkley N, Simonelli C, Lewiecki EM, Lanza F, Chen E, Petruschke RA, Mullen C, de Papp AE. A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. Am J Geriatr Pharmacother. 2005 Sep;3(3):127-36. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis
Secondary To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo
Secondary To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months
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