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A Study to Evaluate the Safety and Tolerability of MK0217 in Women
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00092027
  Purpose

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


Condition Intervention Phase
Postmenopausal Osteoporosis
 Drug: MK0217, alendronate sodium/Duration of Treatment: 6 months
Drug: Comparator: placebo / Duration of Treatment: 6 months
 Phase III

MedlinePlus related topics: Dietary Sodium Osteoporosis
Drug Information available for: Alendronate Alendronate sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: March 2003
  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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.

Study ID Numbers: 2004_017
Study First Received: September 21, 2004
Last Updated: July 6, 2006
ClinicalTrials.gov Identifier: NCT00092027  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal
 Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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