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NCT06264609·Phase 4·INTERVENTIONAL

Precision Medicine Approach for Osteoporosis - Follow Up Study

TeriparatideOtherEnrolling by invitation

Status

Enrolling by invitation

Phase

Phase 4

Enrollment

40

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

This will be a prospective, longitudinal crossover trial for participants who have completed therapy in the main trial - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781. Participants will be informed of the continuation / follow-up study at enrollment into the main trial. Participants will be approached for further participation in the continuation trial near the end of the initial 12 months treatment period. Consent will be obtained at the final visit of the main trial and crossover therapy will be initiated at that time. Participants in Group 1 low turnover, who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Alendronate for 12 months. Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Teriparatide for 12 months. Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy; will be continued on Alendronate for 12 months.

Interventions

Treatment arms and agents.

DRUG

Alendronate

Participants in Group 1 low turnover, who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Alendronate for 12 months.

DRUG

Teriparatide

Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Teriparatide for 12 months.

DRUG

Alendronate

Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy; will be continue on Alendronate for 12 months.

Timeline

From registration to results.

  1. First posted

    Feb 20, 2024

  2. Study start

    Feb 1, 2024

  3. Primary completion

    Dec 31, 2029

  4. Study completion

    Dec 31, 2029

  5. Results posted

    Not reported

  6. Registry updated

    Apr 1, 2026

Outcomes

What the study measures.

Primary outcomes

Percent change in bone loss

Time frame · 12 months

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

Percent change in Bone Mass Density at the hip

Time frame · 12 months

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.

Eligibility

Who can take part.

Minimum age
45 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

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).

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Kentucky

Lexington, Kentucky, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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