Alendronate + Teriparatide for Osteoporosis
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo bone biopsy and blood draws to assess bone turnover status
Treatment
Participants receive either teriparatide or alendronate based on bone turnover status for one year
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alendronate
- Teriparatide
Alendronate is already approved in United States, European Union, Canada for the following indications:
- Prevention and treatment of osteoporosis in postmenopausal women
- Treatment of osteoporosis in men
- Treatment of osteoporosis in postmenopausal women at risk of fracture
- Treatment of osteoporosis in men at risk of fracture
- 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
National Institute on Aging (NIA)
Collaborator