Study of Investigational Drug in Osteoporosis (0217-908)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092053
First received: September 21, 2004
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: MK0217, alendronate sodium/Duration of Treatment: 3 months
Drug: Comparator: placebo / Duration of Treatment: 3 months
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Persistence of the Effect of Oral Monthly Ibandronate on Bone Reception in Postmenopausal Women in Osteoporosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Biochemical markers of bone reception (CTxI and NTx/Cr)

Secondary Outcome Measures:
  • Safety and tolerability

Estimated Enrollment: 180
Study Start Date: January 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women with osteoporosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092053

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092053     History of Changes
Other Study ID Numbers: 0217-908, MK0217-908, 2004_007
Study First Received: September 21, 2004
Last Updated: May 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck Sharp & Dohme Corp.:
Postmenopausal
Osteoporosis

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

ClinicalTrials.gov processed this record on August 18, 2014