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COMPLETED
NCT07660536
PHASE2/PHASE3

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

Sponsor: Creighton University

View on ClinicalTrials.gov

Summary

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

Official title: Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women

Key Details

Gender

FEMALE

Age Range

60 Years - 78 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

1989-11-14

Completion Date

1994-12-23

Last Updated

2026-06-22

Healthy Volunteers

No

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

Locations (1)

Creighton University Medical center

Omaha, Nebraska, United States