Teriparatide vs Alendronate for Osteoporosis

Recruiting in Palo Alto (17 mi)

Overseen byHartmut H Malluche, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Hartmut Malluche, MD

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with osteoporosis, a condition that weakens bones and makes them more likely to break. Participants should have experienced bone loss related to aging rather than menopause. The study aims to help those who haven't benefited from standard treatments.

Inclusion Criteria

I have been diagnosed with osteoporosis based on a bone density scan.

I do not have osteoporosis or any other conditions that would exclude me.

Prior enrollment and completion of therapy in the 'Novel precision medicine approach to treatment of osteoporosis based on bone turnover' trial

+3 more

Exclusion Criteria

Pregnant or trying to become pregnant or are breastfeeding

Planning to move out of the area within 18 months of the study

Chronic alcoholism and/or drug addiction

+10 more

Participant Groups

The study compares two osteoporosis medications: Alendronate, which slows bone loss, and Teriparatide, which helps build new bone. After one year of treatment with one drug, participants will switch to the other for an equal time to see which is more effective.

3Treatment groups

Experimental Treatment

Group I: Group 2 Low Turnover - crossoverExperimental Treatment1 Intervention

Teriparatide

Group II: Group 2 Low Turnover - continuationExperimental Treatment1 Intervention

Alendronate

Group III: Group 1 Low Turnover - crossoverExperimental Treatment1 Intervention

Alendronate

Alendronate is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Fosamax for: