CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 515 enrolled
Drug / intervention
FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol) +2 moredrug
Likely dose
Calcium Supplement 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00692913
NCT00692913Phase 3Completed
CompareCT.gov

A Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of MK -0217A/Alendronate Sodium-70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of Osteoporosis in Postmenopausal Women

Organon and Co·interventional·Posted Jun 6, 2008·Updated May 9, 2024

In Brief

A Phase 3 clinical trial evaluating FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol), Calcium Supplement 500 mg, and 1 other intervention for Osteoporosis. Completed, enrolled 515 participants.

Detailed Summary

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2008
Enrollment StartJun 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.1 years ago

Interventions

FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)drug

FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Calcium Supplement 500 mgdietary

Calcium supplied locally by the investigator (containing 500 mg calcium supplement) daily for 52 weeks (unless the patient's dietary intake of calcium exceeds 1000 mg per day).

Referred-Care Modelother

Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).