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Trial · Interventional

Active, not recruitingPhase 4Registry data

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

NCTNCT05151484 (opens ClinicalTrials.gov in a new tab)Other id70781Other idR01AG072797
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
60 participants (estimated)
Sponsor
Madhumathi Rao · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
21 Mar 2022
Primary completion
31 Jan 2027 (estimated)
Completion
31 Jan 2027 (estimated)
First posted
9 Dec 2021
Last update posted
14 May 2026
Conditions
Age-Related Osteoporosis

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025202620272028
  1. Ph 4

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

    NCT05151484

    21 Mar 2022 to est. 31 Jan 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug
  • AlendronateDrug

Arms3

  • Active comparator

    Group 1 Low Turnover

    Teriparatide (anabolic) For 1 Year

  • Active comparator

    Group 2 Low Turnover

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

  • Active comparator

    Group 3 Normal-High Turnover

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Mineral Bone Density of the lumbar spine

    Time frame · 1 Year

    Registry description

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

  2. Measure of serum osteocalcin levels to predict bone turnover

    Time frame · 1 Year

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures) 2. Treatment naive with respect to with anabolic or antiresorptive bone drugs. 3. Premenopausal, menopausal, and post-menopausal females. 4. 45 years old and older. 5. Presence or absence of diabetes 6. Normal levels of Vitamin D 7. Absence of all exclusion criteria on clinical workup 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. Exclusion Criteria: 1. Pregnant or trying to become pregnant or are breastfeeding. 2. Participation in a study of an investigational drug during the past 30 days. 3. Treatment with anabolic or antiresorptive bone drugs. 4. Use of systemic anticoagulation (blood thinner) 5. Planned or anticipated oral surgery within the next 12 months. 6. Allergy to the antibiotics demeclocycline or tetracycline. 7. Planning to move out of the area within 18 months of the study. 8. Inability to stand or sit upright for at least 30 minutes. 9. Chronic alcoholism and/or drug addiction. 10. Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®)). 11. Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 Diabetes Mellitus). 12. Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections). 13. 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). 14. Have other bone diseases that are not linked to age or menopause. 15. Have a history of malignancy (cancer), not including non-melanoma skin cancer. 16. Vitamin D (Calcidiol) level below the normal range (below 20ng/mL). 17. AFTER RANDOMIZATION: If randomized to Group 1 Teriparatide and radius BMD t-score is less than -3.5 and does not sign consent to continue in the study.

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