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

Condition(s) targeted: Postmenopausal Osteoporosis

Intervention: MK0217, alendronate sodium/Duration of Treatment: 6 months (Drug); Comparator: placebo / Duration of Treatment: 6 months (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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 outcome:

To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo

To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months

Minimum age: 25 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Related publications:

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.

Starting date: March 2003
Last updated: June 9, 2015