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Completed

NCT Number: NCT00092027

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

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

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0217, alendronate sodium/Duration of Treatment: 6 months

Drug

Comparator: placebo / Duration of Treatment: 6 months

Drug

Primary outcomes

  1. 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 outcomes

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

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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 24, 2004
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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