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

NCT05151484 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 70781R01AG072797
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Mineral Bone Density of the lumbar spine

  Percent change in mineral bone density absolute values of the lumbar spine measured by DXA at baseline and at one year.

  1 Year

• Measure of serum osteocalcin levels to predict bone turnover

  Diagnostic Utility of serum osteocalcin level measurements by ELISA at baseline and at one year to predict bone turnover. Area under the receiver operating characteristic curve analysis will be used to determine the discriminative power of osteocalcin levels for determination of low versus non-low bone turnover.

  1 Year

Study Arms (3)

Group 1 Low Turnover

ACTIVE COMPARATOR

Teriparatide (anabolic) For 1 Year

Drug: Teriparatide

Group 2 Low Turnover

ACTIVE COMPARATOR

Standard of Care - Control: Treated with Alendronate (antiresorber) For 1 Year

Drug: Alendronate

Group 3 Normal-High Turnover

ACTIVE COMPARATOR

Standard of Care Treatment with Alendronate (antiresorber) For 1 Year

Drug: Alendronate

Interventions

Teriparatide DRUG

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.

Group 1 Low Turnover

Alendronate DRUG

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.

Group 2 Low Turnover; Group 3 Normal-High Turnover

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures)
• Treatment naive with respect to with anabolic or antiresorptive bone drugs.
• Premenopausal, menopausal, and post-menopausal females.
• years old and older.
• Presence or absence of diabetes
• Normal levels of Vitamin D

You may not qualify if:

• Patients diagnosed as osteoporotic due to the presence of fragility fractures, but without osteoporotic t-scores, will not be included because they would require fractures as a study endpoint which would entail a multi-center approach. Moreover, abnormal bone quality has been shown to be present in these patients, which requires bone histology for assessment.
• Pregnant or trying to become pregnant or are breastfeeding.
• Participation in a study of an investigational drug during the past 30 days.
• Treatment with anabolic or antiresorptive bone drugs.
• Use of systemic anticoagulation (blood thinner)
• Planned or anticipated oral surgery within the next 12 months.
• Allergy to the antibiotics demeclocycline or tetracycline.
• Planning to move out of the area within 18 months of the study.
• Inability to stand or sit upright for at least 30 minutes.
• Chronic alcoholism and/or drug addiction.
• Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®)).
• Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 Diabetes Mellitus).
• Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections).
• Abnormalities of the esophagus (tube connecting the mouth to the stomach) which delay esophageal emptying such as stricture (narrowing) or achalasia (a condition that prevents normal swallowing).
• Have other bone diseases that are not linked to age or menopause.

Sponsors & Collaborators

• Madhumathi Rao: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide; Alendronate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Madhumathi Rao, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madhumathi Rao, MD

CONTACT

859-323-2672; madhumathi.rao@uky.edu

Paul F Netzel, DNP

CONTACT

859-323-2672; pfnetz2@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 9, 2021
• Study Start: March 21, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

US (1)