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Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover

NCT05151484 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-14

No results posted yet for this study

Summary

Osteoporosis affects 24.5% of women over 65 and results in fracture-related hospital admissions exceeding those of heart attacks, strokes and breast cancer combined. Current treatment options do not account for differences between age-related and estrogen deficiency related osteoporosis, because of the need for bone biopsies for determination. This study will establish a paradigm-shifting individualized treatment protocol for age-related osteoporosis and a non-invasive method for its determination, thereby reducing the major health problems and enormous burden on society and the elderly related to this disease.

Conditions

  • Age-Related Osteoporosis

Interventions

DRUG

Teriparatide

Participants will receive 20 μg teriparatide per day via subcutaneous injections. Participants, and if needed a caregiver, will be trained in the subcutaneous administration of teriparatide according to the manufacturer's guidelines. The investigators will measure serum calcium, BSAP and TRAP-5b levels via blood draws at quarterly monitoring visits. If BSAP or TRAP-5b do not increase compared to baseline or decrease after any quarter, participants will be contacted and correct administration will be reviewed. Serum calcium is measured for safety to avoid hypo- and hypercalcemia. Participants will also be given a daily dose of Vitamin D of 800 IUs to prevent development of Vitamin D deficiency.

DRUG

Alendronate

Participants will receive 70 mg alendronate p.o. once per week. Participants will be carefully instructed to follow the manufacturer's recommendations for administration. Compliance will be assessed by measurement of the bone turnover markers BSAP and TRAP-5b from blood drawn at quarterly monitoring visits. These markers have been shown to be useful for assessment of turnover changes with treatment. If these markers do not decrease compared to baseline or rise after any quarter, participants will be contacted and correct administration will be reviewed. Participants will also be given a daily dose of Vitamin D of 800 IUs to prevent development of Vitamin D deficiency.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Madhumathi Rao

    lead OTHER

Principal Investigators

  • Madhumathi Rao, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05151484 on ClinicalTrials.gov