Precision Medicine Approach for Osteoporosis - Follow Up Study

NCTNCT06264609Other id91026

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Overview

Status: Enrolling by invitation
Phase: Phase 4
Enrollment: 40 participants (estimated)
Sponsor: Paul F Netzel · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 1 Feb 2024
Primary completion: 31 Dec 2029 (estimated)
Completion: 31 Dec 2029 (estimated)
First posted: 20 Feb 2024
Last update posted: 1 Apr 2026
Conditions: Osteoporosis

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2024202520262027202820292030

Ph 4
Precision Medicine Approach for Osteoporosis - Follow Up Study
NCT06264609
1 Feb 2024 to est. 31 Dec 2029

Registry summary

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

Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality. Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem. Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.

Interventions

AlendronateDrug
TeriparatideDrug
AlendronateDrug

Arms3

Experimental
Group 1 Low Turnover - crossover
Alendronate
Experimental
Group 2 Low Turnover - crossover
Teriparatide
Experimental
Group 2 Low Turnover - continuation
Alendronate

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent change in bone loss
Time frame · 12 months
Registry description
The primary endpoint for the follow up study will be bone loss as determined by the percent change in DXA absolute values of the lumbar spine, femoral neck, total hip and radius measured at baseline, at the end of the one-year trial; and at end of the one year follow up study. DXA is chosen because of its wide availability, low radioactivity exposure, and clinical use.

Secondary outcomes(1)

Percent change in Bone Mass Density at the hip
Time frame · 12 months
Registry description
Secondary endpoints will be percent change in BMD at the hip measured at baseline, at the end of the one-year trial; and at end of the one year follow up study. DXA is chosen because of its wide availability, low radioactivity exposure, and clinical use.

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: Female
Age: from 45 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. Prior enrollment and completion of therapy in the "Novel precision medicine approach to treatment of osteoporosis based on bone turnover" trial.3) Premenopausal, menopausal, and post-menopausal females. 3. 45 years old and older. 4. Normal levels of Vitamin D 5. Absence of all exclusion criteria on clinical workup. Patients diagnosed as osteoporotic due to the presence of Exclusion Criteria: 1. Pregnant or trying to become pregnant or are breastfeeding 2. Use of systemic anticoagulation (blood thinner) 3. Planned or anticipated oral surgery within the next 12 months 4. Planning to move out of the area within 18 months of the study 5. Inability to stand or sit upright for at least 30 minutes 6. Chronic alcoholism and/or drug addiction 7. Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®)) 8. Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus) 9. Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections) 10. 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) 11. Have other bone diseases that are not linked to age or menopause 12. Have a history of malignancy (cancer), not including non-melanoma skin cancer. 13. Vitamin D (Calcidiol) level below the normal range (below 20ng/mL).

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