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Anti-resorptive agent

Teriparatide vs Alendronate 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
Must not have
Inability to stand or sit upright for at least 30 minutes
Have a history of malignancy (cancer), not including non-melanoma skin cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

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.
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.
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
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I have been diagnosed with osteoporosis based on a bone density scan.
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I am a woman who may be before, during, or after menopause.
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I am 45 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot sit or stand up straight for 30 minutes.
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I have had cancer before, but not skin cancer.
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I plan to have oral surgery in the next year.
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I have bone conditions not related to aging or menopause.
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I have a condition that makes it hard for food to move from my mouth to my stomach.
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I am currently taking medication to prevent blood clots.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change in bone loss
Secondary study objectives
Percent change in Bone Mass Density at the hip
Other study objectives
Trabecular bone score (TBS)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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
~27 spots leftby Dec 2029
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