MedTrace Logo

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

NCT01350934 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2024-06-20

Study results available
· View outcomes & findings →

Summary

This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus)

one combination tablet once weekly

DRUG

Calcitriol

0.25 μg once daily orally

DIETARY_SUPPLEMENT

Calcium 500 mg

one 500 mg tablet once daily

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
56 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-19
Primary Completion
2013-01-10
Completion
2013-01-10

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01350934 on ClinicalTrials.gov