MedTrace Logo

To Study the Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women in a Long Term 2 Year Study

NCT07660536 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-01

No results posted yet for this study

Summary

A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women

Conditions

  • Osteoporosis (Senile)

Interventions

DRUG

doxercalciferol capsules, Hectorol®

doxercalciferol capsules given in escalating doses from 1mcg to 5mcg daily.If serum calcium is elevated at any dose then that dose is maintained long term for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months

DRUG

Matched Placebo (Capsules)

oral doses increased from 1 to 5mcg once daily until serum calcium is elevated and given for 2 years.The change in bone mineral density will be measured at baseline ,12 and 24 months

Sponsors & Collaborators

  • Creighton University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
78 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1989-11-14
Primary Completion
1992-04-22
Completion
1994-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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 NCT07660536 on ClinicalTrials.gov