← Back to Search

Anti-resorptive agent

Group 2 Low Turnover - crossover for Osteoporosis

Phase 4

Waitlist Available

Led By Hartmut H Malluche, MD

Research Sponsored by Hartmut Malluche, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed Osteoporosis by DXA (BMD t-score = -2.5 with or without fragility fractures)

Premenopausal, menopausal, and post-menopausal females

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial aims to address the issue of age-related bone loss, which is often overlooked in current osteoporosis treatments. The study compares the effectiveness of two drugs, Alendronate and Terip

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Alendronate may cause digestive issues like heartburn or ulcers, muscle pain, and rarely jawbone problems. Teriparatide can lead to increased calcium levels in blood, dizziness or leg cramps, and sometimes injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am a woman who may be before, during, or after menopause.

Select...

I am 45 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change in bone loss

Secondary outcome measures

Percent change in Bone Mass Density at the hip

Other outcome measures

Trabecular bone score (TBS)

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Teriparatide

2006

Completed Phase 4

~3150

Alendronate

2012

Completed Phase 4

~6930

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hartmut Malluche, MDLead Sponsor

3 Previous Clinical Trials

665 Total Patients Enrolled

1 Trials studying Osteoporosis

60 Patients Enrolled for Osteoporosis

Hartmut H Malluche, MDPrincipal InvestigatorUniversity of Kentucky

1 Previous Clinical Trials

464 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"Per information from clinicaltrials.gov, the current status of this trial is not recruiting participants. The trial was first listed on 2/1/2024 and most recently revised on 2/9/2024. Although enrollment is temporarily closed, there are currently 116 alternative trials actively seeking participants."

Answered by AI