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Bisphosphonate

Alendronate + Teriparatide for Osteoporosis

Phase 4
Recruiting
Led By hartmut h Mallluche, 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
45 years old and older
Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures)
Must not have
Have other bone diseases that are not linked to age or menopause
Inability to stand or sit upright for at least 30 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will help create a new, better way to treat osteoporosis that accounts for the different ways it can develop in people.

Who is the study for?
This trial is for women aged 45 and older with diagnosed osteoporosis (bone density score ≤ -2.5), who haven't used bone drugs before, regardless of menopause status or diabetes presence. Exclusions include chronic substance abuse, certain systemic illnesses affecting bones, pregnancy, recent participation in other drug trials, planned surgeries within a year, inability to sit/stand for 30 minutes, and plans to move away soon.
What is being tested?
The study tests Alendronate versus Teriparatide as treatments for osteoporosis in postmenopausal women. It aims to tailor treatment based on non-invasive determination of age-related bone loss without needing biopsies—potentially revolutionizing how this common condition is managed.
What are the potential side effects?
Alendronate may cause digestive issues like heartburn or ulcers; rarely jaw problems or unusual thigh bone fractures. Teriparatide can lead to increased calcium levels in the blood, leg cramps or dizziness; infrequently it might be linked with an increased risk of bone cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 45 years old or older.
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I have been diagnosed with osteoporosis based on a DXA scan.
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I have diabetes.
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I am a woman who may be before, during, or after menopause.
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I have been diagnosed with osteoporosis based on a bone density scan.
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I have not taken any bone-strengthening drugs.
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I am 40 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 have bone conditions not related to aging or menopause.
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I cannot sit or stand up straight for 30 minutes.
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I plan to have oral surgery in the next year.
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I have had cancer before, but not skin cancer.
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I am currently taking medication to prevent blood clots.
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I have no illnesses affecting my bones, except possibly diabetes.
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I chose not to continue in the study after learning my bone density score.
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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 taking medication for bone strengthening or growth.
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I am allergic to demeclocycline or tetracycline antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure of serum osteocalcin levels to predict bone turnover
Mineral Bone Density of the lumbar spine

Awards & Highlights

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

Trial Design

3Treatment groups
Active Control
Group I: Group 3 Normal-High TurnoverActive Control1 Intervention
Standard of Care Treatment with Alendronate (antiresorber) For 1 Year
Group II: Group 1 Low TurnoverActive Control1 Intervention
Teriparatide (anabolic) For 1 Year
Group III: Group 2 Low TurnoverActive Control1 Intervention
Standard of Care - Control: Treated with Alendronate (antiresorber) For 1 Year

Find a Location

Who is running the clinical trial?

Hartmut Malluche, MDLead Sponsor
3 Previous Clinical Trials
645 Total Patients Enrolled
1 Trials studying Osteoporosis
40 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,785 Previous Clinical Trials
28,184,676 Total Patients Enrolled
23 Trials studying Osteoporosis
12,195 Patients Enrolled for Osteoporosis
hartmut h Mallluche, mdPrincipal InvestigatorUniversity of Kentucky

Media Library

Alendronate (Bisphosphonate) Clinical Trial Eligibility Overview. Trial Name: NCT05151484 — Phase 4
Osteoporosis Research Study Groups: Group 3 Normal-High Turnover, Group 1 Low Turnover, Group 2 Low Turnover
Osteoporosis Clinical Trial 2023: Alendronate Highlights & Side Effects. Trial Name: NCT05151484 — Phase 4
Alendronate (Bisphosphonate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05151484 — Phase 4
~24 spots leftby Aug 2026
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