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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092027
First Posted: September 24, 2004
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 454
Actual Study Start Date: March 19, 2003
Study Completion Date: March 15, 2004
Primary Completion Date: March 15, 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092027


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092027     History of Changes
Other Study ID Numbers: 0217-219
MK0217-219
2004_017
First Submitted: September 21, 2004
First Posted: September 24, 2004
Last Update Posted: March 28, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs