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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two medications, Teriparatide and Alendronate, in treating osteoporosis, a condition where bones weaken and are more prone to fractures. The trial aims to assess the impact of switching treatments after the first year on bone health. It targets individuals diagnosed with osteoporosis who have completed a previous related study. Participants should have normal Vitamin D levels and no other bone diseases unrelated to age or menopause. As a Phase 4 trial, this research seeks to understand how these FDA-approved treatments can benefit more patients.

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 is the safety track record for these treatments?

Research shows that both teriparatide and alendronate are generally safe for treating osteoporosis, but each has specific considerations.

Studies indicate that teriparatide is safe for use, but it should not be used for more than two years due to insufficient long-term safety data. Reported side effects include pain, muscle spasms, and nausea, with a rare warning about a possible increased risk of bone cancer.

Alendronate is well-known for preventing and treating osteoporosis. The FDA has approved it, and it has been shown to strengthen bones and reduce fracture risk. Some individuals might experience side effects like stomach pain or muscle pain, and there is a small risk of unusual thigh bone fractures with long-term use.

Overall, both treatments are considered safe, but participants should discuss any concerns with their healthcare provider before joining a study. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for osteoporosis because they offer distinct benefits over traditional options. Teriparatide is unique because it is a form of parathyroid hormone that stimulates bone growth, making it different from the standard bisphosphonates like Alendronate, which mainly prevent bone breakdown. This new approach could potentially lead to stronger bones and a reduced risk of fractures. Meanwhile, Alendronate, when tested in different sequences, provides insights into optimizing bone health by slowing bone loss and possibly maintaining bone density more effectively in certain patient groups. Together, these treatments might offer more tailored and effective strategies for managing osteoporosis.

What evidence suggests that this trial's treatments could be effective for osteoporosis?

This trial will compare Teriparatide and Alendronate for managing osteoporosis. Research has shown that Teriparatide, which participants in this trial may receive, can reduce the risk of new spinal fractures by up to 65% and increase bone strength by 9%. Its benefits persist, resulting in fewer fractures even years after treatment. Alendronate, another treatment option in this trial, reduces the risk of spine fractures by 61% and effectively strengthens bones, particularly in the spine, over long periods. Both treatments have proven effective in managing osteoporosis, but they work differently. Teriparatide helps build new bone, while Alendronate slows bone loss. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul Netzel, DNP

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38753892/

Comparative effectiveness of denosumab vs alendronate ... Although clinical trials have shown that denosumab is more effective at increasing bone mineral density compared with alendronate, there is a lack of evidence.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2790676023000419

Comparative efficacy and safety of bisphosphonate therapy ... Regarding the primary efficacy outcome, there was a 97% probability for alendronate to be the most effective treatment approach for increasing bone mineral ...

3. amjmed.com amjmed.com/article/S0002-9343(24)00101-3/fulltext

Reconsidering the Benefits of Osteoporosis Treatment Based on the ACP analysis, bisphosphonates reduce symptomatic vertebral fracture risk by 61%, with a corresponding 1.8% absolute risk reduction.

4. nature.com nature.com/articles/s41598-020-68037-8

Comparative safety and effectiveness of alendronate ... In the primary analysis, there were 8.18 vertebral fracture, 1.14 AFF, 0.21 esophageal cancer, and 0.09 ONJ outcomes per 1,000 person-years in ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa030897

Ten Years' Experience with Alendronate for Osteoporosis ... Alendronate appeared to be effective over the 10-year period of the study. The observed increases in bone mineral density at the lumbar spine during long ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/alendronate-oral-route/description/drg-20061571

Alendronate (oral route) - Side effects & dosage Alendronate is used to prevent and treat osteoporosis (thinning of the bone) in women after menopause.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK526073/

Alendronate - StatPearls - NCBI Bookshelf - NIH Alendronate is approved by the US Food and Drug Administration (FDA) for the treatment of postmenopausal osteoporosis, steroid-induced osteoporosis, and male ...

8. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-update-osteoporosis-drugs-bisphosphonates-and-atypical

Safety update for osteoporosis drugs, bisphosphonates ... Be aware of the possible risk of atypical subtrochanteric and diaphyseal femur fractures in patients taking bisphosphonates. Continue to follow ...

9. webmd.com webmd.com/drugs/2/drug-1257-7174/alendronate-oral/alendronate-oral/details

Alendronate (Binosto, Fosamax): Uses, Side Effects, ... Alendronate slows the natural breakdown of your bones. This helps them stay stronger and reduces the risk for bone fractures.

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/021575s017lbl.pdf

Fosamax (alendronate sodium) tablets label The safety and effectiveness of FOSAMAX for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has ...