60 Participants Needed

Alendronate + Teriparatide for Osteoporosis

HH
DT
PF
MR
Overseen ByMadhumathi Rao, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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.12345

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.12346

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.23478

Who Is on the Research Team?

MR

Madhumathi Rao, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.
See 8 more

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.
See 14 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

  • Alendronate
  • Teriparatide
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.
How Is the Trial Designed?
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

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
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Approved in Canada as Fosamax for:
  • Treatment of osteoporosis in postmenopausal women
  • Treatment of osteoporosis in men

Find a Clinic Near You

Who Is Running the Clinical Trial?

Madhumathi Rao

Lead Sponsor

Hartmut Malluche, MD

Lead Sponsor

Trials
4
Recruited
710+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

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.
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.
Spotlight on teriparatide in osteoporosis.Blick, SK., Dhillon, S., Keam, SJ.[2016]
After one year of treatment with teriparatide, all groups of postmenopausal women with osteoporosis showed significant increases in lumbar spine bone mineral density (BMD), with the treatment-naïve group experiencing the highest increase of 8.4%.
The treatment-naïve group also showed a significant increase in total hip BMD, while the groups with prior antiresorptive treatment did not show any improvement in hip BMD, indicating that teriparatide may be more effective in patients who have not previously received osteoporosis treatment.
Bone density after teriparatide in patients with or without prior antiresorptive treatment: one-year results from the EUROFORS study.Minne, H., Audran, M., Simões, ME., et al.[2022]

Citations

Teriparatide: a review of its use in osteoporosis. [2021]
Spotlight on teriparatide in osteoporosis. [2016]
Bone density after teriparatide in patients with or without prior antiresorptive treatment: one-year results from the EUROFORS study. [2022]
Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial. [2019]
Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass. [2022]
Effects of teriparatide versus alendronate for treatment of postmenopausal osteoporosis: A meta-analysis of randomized controlled trials. [2021]
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]
Effects of bone remodeling agents following teriparatide treatment. [2019]
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