Alendronate + Teriparatide for Osteoporosis

Recruiting in Palo Alto (17 mi)

Overseen by hartmut h Mallluche, md

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Hartmut Malluche, MD

Must not be taking: Anticoagulants, Anabolic drugs

Disqualifiers: Pregnancy, Oral surgery, Cancer, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Osteoporosis affects 24.5% of women over 65 and results in fracture-related hospital admissions exceeding those of heart attacks, strokes and breast cancer combined. Current treatment options do not account for differences between age-related and estrogen deficiency related osteoporosis, because of the need for bone biopsies for determination. This study will establish a paradigm-shifting individualized treatment protocol for age-related osteoporosis and a non-invasive method for its determination, thereby reducing the major health problems and enormous burden on society and the elderly related to this disease.

Will I have to stop taking my current medications?

The trial requires that participants have not been treated with anabolic or antiresorptive bone drugs before. If you are currently taking these types of medications, you would need to stop them to participate.

What data supports the effectiveness of the drugs Alendronate and Teriparatide for treating osteoporosis?

Research shows that Teriparatide is effective in improving bone mineral density and reducing fracture risk in people with osteoporosis, including postmenopausal women and men with certain types of osteoporosis. Alendronate, another osteoporosis drug, works by slowing bone loss, and when combined with Teriparatide, it may enhance overall bone health. ^{1 2 3 4 5}

Is the combination of Alendronate and Teriparatide safe for treating osteoporosis?

Teriparatide is generally well tolerated and has been shown to improve bone density and reduce fracture risk in people with osteoporosis. Alendronate is also used for osteoporosis and works differently by slowing bone loss. Both drugs have been studied separately and are considered safe for treating osteoporosis, but specific safety data on their combined use is limited. ^{1 2 4 6 7}

How is the drug combination of Alendronate and Teriparatide unique for treating osteoporosis?

The combination of Alendronate and Teriparatide is unique because it uses both an anabolic agent (Teriparatide) to build bone and an antiresorptive agent (Alendronate) to prevent bone loss, potentially offering a more comprehensive approach to improving bone density and reducing fracture risk compared to using either drug alone. ^{1 2 4 6 8}

Research Team

hartmut h Mallluche, md

Principal Investigator

University of Kentucky

Eligibility Criteria

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.

Inclusion Criteria

Absence of all exclusion criteria on clinical workup

I am 45 years old or older.

I have been diagnosed with osteoporosis based on a DXA scan.

Exclusion Criteria

I have bone conditions not related to aging or menopause.

I cannot sit or stand up straight for 30 minutes.

I plan to have oral surgery in the next year.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo bone biopsy and blood draws to assess bone turnover status

1 week

1 visit (in-person)

Treatment

Participants receive either teriparatide or alendronate based on bone turnover status for one year

52 weeks

Regular visits (in-person) for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Alendronate (Bisphosphonate)
• Teriparatide (Osteoporosis agent)

Trial Overview 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.

Participant Groups

Group I: Group 3 Normal-High Turnover Active Control 1 Intervention

Standard of Care Treatment with Alendronate (antiresorber) For 1 Year

Group II: Group 1 Low Turnover Active Control 1 Intervention

Teriparatide (anabolic) For 1 Year

Group III: Group 2 Low Turnover Active Control 1 Intervention

Standard of Care - Control: Treated with Alendronate (antiresorber) For 1 Year

Alendronate is already approved in Canada for the following indications:

Approved in Canada as Fosamax for:

• Treatment of osteoporosis in postmenopausal women
• Treatment of osteoporosis in men

Who Is Running the Clinical Trial?

Hartmut Malluche, MD

Lead Sponsor

Trials

4

Recruited

710+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

Recombinant teriparatide (Forteo) is an effective anabolic treatment for osteoporosis, significantly improving bone mineral density and reducing fracture risk in various patient groups, including postmenopausal women and men with idiopathic or glucocorticoid-induced osteoporosis, over a treatment period of 11-21 months.

Teriparatide is generally well tolerated, but due to treatment duration limits and high costs, it is recommended primarily for patients at high fracture risk or those who do not respond well to other osteoporosis treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teriparatide: a review of its use in osteoporosis. Blick, SK., Dhillon, S., Keam, SJ.[2021]

Recombinant teriparatide (20 microg/day) is effective in increasing bone mineral density and reducing fracture risk in various osteoporosis patients, including postmenopausal women and men with idiopathic or hypogonadal osteoporosis, over a treatment period of 11-21 months.

The positive effects of teriparatide on bone health, including vertebral fracture prevention, continue even after treatment ends, making it a valuable option for high-risk osteoporosis patients, despite its high cost and treatment duration limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on teriparatide in osteoporosis. Blick, SK., Dhillon, S., Keam, SJ.[2016]

In a study involving 159 patients with femoral neck fractures, teriparatide did not show a significant improvement in reducing the need for revision surgery or enhancing radiographic fracture healing compared to placebo.

The safety profile of teriparatide was consistent with previous findings, as the rate of adverse events was similar between the teriparatide and placebo groups, indicating that it is safe for use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial. Bhandari, M., Jin, L., See, K., et al.[2019]

In a study of 203 postmenopausal women with osteoporosis over 18 months, teriparatide significantly increased bone mineral density (BMD) and markers of bone turnover, indicating its effectiveness in stimulating bone formation compared to alendronate, which suppresses bone remodeling.

At 18 months, teriparatide resulted in greater increases in areal and volumetric spine BMD (10.3% and 19.0%, respectively) compared to alendronate (5.5% and 3.8%), highlighting the different mechanisms of action between the two treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass. McClung, MR., San Martin, J., Miller, PD., et al.[2022]

In a systematic review of 6 trials with 618 postmenopausal osteoporosis patients, teriparatide significantly increased lumbar spine bone mineral density (BMD) compared to alendronate, particularly notable at 12 months of treatment.

However, teriparatide did not show a superior ability to reduce fracture risk compared to alendronate, indicating that while it may improve bone density, both treatments have similar safety profiles regarding fracture prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of teriparatide versus alendronate for treatment of postmenopausal osteoporosis: A meta-analysis of randomized controlled trials. Wang, YK., Qin, SQ., Ma, T., et al.[2021]

In a study of 1,648 postmenopausal women with osteoporosis treated with teriparatide for up to 18 months, there was a significant 47% reduction in the odds of experiencing fragility fractures during the last 6 months compared to the first 6 months.

Patients also reported a notable decrease in back pain and improvements in health-related quality of life, with safety profiles aligning with existing prescribing information, indicating that teriparatide is effective and generally safe for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS). Langdahl, BL., Rajzbaum, G., Jakob, F., et al.[2022]

In a study of 64 patients who completed 2 years of teriparatide treatment, those who switched to denosumab experienced the greatest increase in bone mineral density (BMD) at both the lumbar spine (4.94%) and femoral neck (5.68%) after an additional 2 years.

Patients who stopped osteoporosis treatment after teriparatide showed a significant decline in BMD, increasing their risk of fragility fractures, highlighting the importance of continued treatment with antiresorptive drugs like denosumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of bone remodeling agents following teriparatide treatment. Burkard, D., Beckett, T., Kourtjian, E., et al.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Teriparatide: a review of its use in osteoporosis. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on teriparatide in osteoporosis. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Bone density after teriparatide in patients with or without prior antiresorptive treatment: one-year results from the EUROFORS study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of teriparatide versus alendronate for treatment of postmenopausal osteoporosis: A meta-analysis of randomized controlled trials. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS). [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of bone remodeling agents following teriparatide treatment. [2019]