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

Conditions

• Osteoporosis (Senile)

Eligibility Criteria

Sex

FEMALE

Age

60 Years - 78 Years

Healthy Volunteers

Not accepted

Interventions

• doxercalciferol capsules, Hectorol® — DRUG
  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
• Matched Placebo (Capsules) — DRUG
  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

Study Details

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

Key Dates

Start date

Nov 14, 1989

Status verified

Dec 1992

Primary completion

Apr 22, 1992

Completion

Dec 23, 1994

Study Design

Enrollment

60 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Placebo Comparator: doxercalciferol capsules
  placebo capsule are given in increasing doses weekly from 1 to 5 mcg daily over 6 weeks and continued for 24 months or if serum calcium is elevated at a lower dose then the patient will be continued on the lower dose for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months
• Experimental: prevention of osteoporosis
  doxercalciferol capsule are given in increasing doses weekly from 1 to 5 mcg daily over 6 weeks and continued for 24 months or if serum calcium is elevated at a lower dose then the patient will be continued on the lower dose for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months

Primary Outcome Measure

change in spine and femur density over 2 years [ Time Frame: Baseline, 6,12,18,24 months at study completion ]

Locations (1)

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