A Study to Compare the Efficacy of Alendronate With and Without Calcium or Calcium Alone In the Treatment of Osteoporosis in Postmenopausal Women (0217-088)(COMPLETED)

Osteoporosis, Postmenopausal Clinical Trial

Official title:

A Triple-Blind, Randomized, Active-Controlled, Parallel-Group, Multicenter Study to Evaluate and Compare the Efficacy and Tolerability of Alendronate Sodium With Calcium Supplementation in the Treatment of Osteoporosis in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398606
• Other study ID #: 0217-088
• Secondary ID: 2006_546
• Status: Completed
• Phase: Phase 3
• Start date: April 1995

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. primary completion date: February 1998
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria :

• Patient is postmenopausal (or surgically menopausal) for at least 5 years.

• Patient must be diagnosed with osteoporosis

• Patient has spinal anatomy suitable for DEXA of the lumbar spine

Exclusion Criteria :

• Patient is receiving or has received treatment prior to randomization which might influence bone turnover

• Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)

• Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• MK0217, alendronate sodium / Duration of Treatment : 2 Years

• Comparator : calcium carbonate /Duration of Treatment : 2 Years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Bonnick S, Broy S, Kaiser F, Teutsch C, Rosenberg E, DeLucca P, Melton M. Treatment with alendronate plus calcium, alendronate alone, or calcium alone for postmenopausal low bone mineral density. Curr Med Res Opin. 2007 Jun;23(6):1341-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD of the lumbar spine determined by a DEXA scan at 2 years
Secondary	BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years