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 | Completed Phase 2 FDA Drug

• 1 other identifier: H-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

randomized trial,doxercalciferol,bone density spine and femoral neck,

Outcome Measures

Primary Outcomes (1)

• change in spine and femur density over 2 years

  measurements every 6 months over 2 years

  Baseline, 6,12,18,24 months at study completion

Secondary Outcomes (1)

• safety of doxercalciferol on serum and urine calcium excretion

  From enrollment ,measurements at baseline, weeks 1,2,3,4,5,12 after first dose, then every 3 months until study completion at 24 months

Other Outcomes (1)

• efficacy of doxerxalciferol in stimulating calcium absorption

  Baseline , 6months,12 months

Study Arms (2)

doxercalciferol capsules

PLACEBO COMPARATOR

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

Drug: Matched Placebo (Capsules)

prevention of osteoporosis

EXPERIMENTAL

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

Drug: doxercalciferol capsules, Hectorol®

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

prevention of osteoporosis

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

doxercalciferol capsules

Eligibility Criteria

• Age: 60 Years - 78 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• postmenopausal women, age 60-78 years
• normal general laboratory tests
• serum calcium \>10.6 mg/dl (2.65 mmol/L ) or \>0.3 mg/dl (0.075mmol/L) above upper limit of normal on 2 baseline tests,
• hour urine calcium \< 300mg (7.5mmol) on two baseline tests,
• Bone mineral density (BMD) measured by DEXA of the spine vertebrae L2-3 of 0.70-1.05 g/cm2

You may not qualify if:

• no significant medical disorder known to affect calcium or bone metabolism- hypercalcemia, active renal stone disease ( more than 1 stone episode/ year) or more than 2 stone episodes in a lifetime, sarcoidosis
• severe chronic illness, chronic renal failure ( serum creatinine \>1.4mg/dl ,chronic heart failure,
• any terminal illness
• any history of cancer (except skin cancer) within the last 10 years,
• uncontrolled diabetes with significant proteinuria or fasting blood sugar \> 140mg/dl
• alcoholism
• prolonged hospitalization , extended immobilizations or arthritis that prevents normal physical activity, hemiplegia, previous hip fracture
• no previous treatment with medication known to affect bone and calcium metabolism within the last year; chronic corticosteroid therapy \> 10mg/day thiazides, taking long term bisphosphonates or had them for more than 3 months in the past year, parathyroid hormone or derivatives in the last year, estrogen therapy within the last 6 months, anticonvulsants such as phenytoin ,high dose phenobarbital
• BMI \> 45kg/m2

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University Medical center

Omaha, Nebraska, 68132, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

1 alpha-hydroxyergocalciferol; Capsules

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blind , placebo control

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: November 14, 1989
• Primary Completion: April 22, 1992
• Study Completion: December 23, 1994
• Last Updated: July 1, 2026

Record last verified: 1992-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: September 1 ,2026
• Access Criteria: Criteria for sharing to investigators in calcium/bone area .Results on bone density ,on serum/urine calcium .A proposal for planned analysis to be submitted,.I will personally review the application

Locations

US (1)