Teriparatide vs Alendronate for Osteoporosis

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Paul F Netzel

Must not be taking: Blood thinners

Disqualifiers: Pregnancy, Oral surgery, Alcoholism, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using blood thinners or have certain health conditions, you may not be eligible to participate.

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

Research shows that Teriparatide, which helps build new bone, and Alendronate, which slows bone loss, are both effective for treating osteoporosis. A study found that using Teriparatide followed by Alendronate reduced the risk of fractures more than using Alendronate alone. ^{1 2 3 4 5}

Is teriparatide or alendronate safe for treating osteoporosis?

Both teriparatide and alendronate are generally considered safe for treating osteoporosis. Teriparatide has a favorable safety profile, and alendronate has been shown to be effective and safe in large studies, though it should be taken with water to avoid esophageal irritation. ^{1 3 6 7 8}

How does the drug Alendronate differ from other osteoporosis treatments?

Alendronate is unique because it is an antiresorptive agent, meaning it works by slowing down the process that breaks down bone, helping to maintain bone density. This is different from teriparatide, which is an anabolic (bone-forming) drug that actively stimulates new bone growth. ^{1 9 10 11 12}

Research Team

Paul Netzel, DNP

Principal Investigator

University of Kentucky

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Crossover Treatment

Participants switch from their initial treatment to the other drug for 12 months

12 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at baseline, end of one-year trial, and end of follow-up

Treatment Details

Interventions

• Alendronate
• Teriparatide

Trial Overview 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.

Participant Groups

Group I: Group 2 Low Turnover - crossover Experimental Treatment 1 Intervention

Teriparatide

Group II: Group 2 Low Turnover - continuation Experimental Treatment 1 Intervention

Alendronate

Group III: Group 1 Low Turnover - crossover Experimental Treatment 1 Intervention

Alendronate

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

Approved in United States as Fosamax for:

• Prevention and treatment of osteoporosis in postmenopausal women
• Treatment of osteoporosis in men

Approved in European Union as Fosamax for:

• Treatment of osteoporosis in postmenopausal women at risk of fracture
• Treatment of osteoporosis in men at risk of fracture

Approved in Canada as Fosamax for:

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

Who Is Running the Clinical Trial?

Paul F Netzel

Lead Sponsor

Hartmut Malluche, MD

Lead Sponsor

Trials

4

Recruited

710+

Findings from Research

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 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]

Alendronate is an effective treatment for osteoporosis in postmenopausal women, significantly reducing the risk of vertebral and nonvertebral fractures, as shown in large randomized controlled trials lasting up to 3 years.

The drug works by inhibiting osteoclast activity, which helps prevent bone loss without increasing the risk of osteomalacia, making it a safe option for increasing bone mass in women with osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug clinics. The drug of the month. Alendronate (Fosamax)]. Scheen, AJ.[2015]

Alendronate (Fosamax) has been shown to significantly increase bone mineral density in postmenopausal women and reduce the risk of new vertebral and hip fractures by about 50%, based on evidence from six randomized controlled trials involving 3854 participants.

The treatment is well tolerated with no adverse effects on bone mineralization or microstructure, making alendronate a safe and effective nonhormonal therapy for osteoporosis in postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alendronate for osteoporosis. Safe and efficacious nonhormonal therapy. Adachi, JD.[2018]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Sequential therapy with once-weekly teriparatide injection followed by alendronate versus monotherapy with alendronate alone in patients at high risk of osteoporotic fracture: final results of the Japanese Osteoporosis Intervention Trial-05. [2023]

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

Effects of teriparatide, alendronate, or both on bone turnover in osteoporotic men. [2013]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Comparative effects of teriparatide and ibandronate on spine bone mineral density (BMD) and microarchitecture (TBS) in postmenopausal women with osteoporosis: a 2-year open-label study. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of teriparatide vs alendronate in postmenopausal osteoporosis: a prospective non randomized clinical study. [2020]

7. Belgium pubmed.ncbi.nlm.nih.gov

[Drug clinics. The drug of the month. Alendronate (Fosamax)]. [2015]

8. Canada pubmed.ncbi.nlm.nih.gov

Alendronate for osteoporosis. Safe and efficacious nonhormonal therapy. [2018]

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

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

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

Spotlight on teriparatide in osteoporosis. [2016]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Four-Year Teriparatide Followed by Denosumab vs. Continuous Denosumab in Glucocorticoid-Induced Osteoporosis Patients With Prior Bisphosphonate Treatment. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

[Teriparatide: an anabolic drug for the treatment of patients with osteoporosis]. [2013]