Ongoing Clinical Trials for Osteoporosis
There are currently 9 clinical trials investigating various treatments for osteoporosis, a condition where bones become weak and more likely to break. These studies are testing medications including bisphosphonates, bone-building treatments, and combinations of drugs aimed at strengthening bones and reducing fracture risk. Trials are being conducted in several European countries, primarily Denmark, as well as Austria, Bulgaria, Czechia, and Poland.
Clinical trial locations
- Austria
- Bulgaria
- Czechia
- Denmark
- Study on Dasatinib and Quercetin for Patients with Osteoporosis or Osteopenia
- Study on Dasatinib and Quercetin or Nicotinamide Riboside for Patients with Osteoporosis or Osteopenia
- Study on the Effects of Alendronate on Bone and Blood Sugar Markers in Patients with Diabetes and Osteopenia/Osteoporosis
- Study on the Effects of Stopping Alendronic Acid in Patients with Osteoporosis
- Study on the Use of Romosozumab and Zoledronic Acid for Treating Osteoporosis in Patients
- Study on Zoledronic Acid Following Denosumab for Osteoporosis Patients
- Poland
Study on Dasatinib and Quercetin for Patients with Osteoporosis or Osteopenia
This trial is investigating the combination of dasatinib, a protein kinase inhibitor, with either quercetin or nicotinamide riboside for treating people with low bone mass. The study aims to evaluate whether this treatment can reduce bone resorption, which is the process where bone is broken down and minerals are released into the bloodstream.
Who can participate: The trial is open to men and women aged 60-90 years. Women must be at least 5 years past menopause with appropriate hormone levels. Participants need to have an increased fracture risk according to the WHO’s Fracture Risk Assessment Tool and must have either osteopenia or osteoporosis based on bone density measurements. Specifically, eligible participants may have osteopenia with a T-score between -2 and -2.5, or osteoporosis with a T-score between -3 and -2.5. All participants must be able to understand the study and provide informed consent.
Who cannot participate: Individuals with conditions other than osteopenia or osteoporosis, those outside the specified age range, and people considered part of vulnerable populations are excluded from participation.
Study focus: The 21-week study will monitor various markers of bone health, including CTX, a circulating marker of bone resorption, as well as markers related to bone formation. Participants will receive either the treatment combination or a placebo, with regular assessments throughout the study period.
Investigational drugs: Dasatinib is being studied for its potential to reduce bone breakdown. Quercetin, a natural substance found in fruits and vegetables, and nicotinamide riboside, a form of vitamin B3, are both being tested for their potential to support bone health when combined with dasatinib.
Study on the Effects of Alendronate on Bone and Blood Sugar Markers in Patients with Diabetes and Osteopenia/Osteoporosis
This trial examines how alendronate affects both bone health and blood sugar control in patients with diabetes who also have osteopenia or osteoporosis. The study will compare alendronate treatment with a placebo over a period of up to 24 months.
Who can participate: Eligible participants must have either type 1 or type 2 diabetes and be 50 years old or older. They must have been on the same diabetes treatment for at least six months, though dose changes are allowed. Participants need an HbA1c level of 6.7% or higher, a Body Mass Index between 19 and 35, and a bone density T-score between -3.5 and -0.5. Both men and women can participate.
Who cannot participate: Pregnant or breastfeeding women, individuals with severe kidney problems, people with a history of allergic reactions to the study medication, those who have taken similar medications recently, participants unable to follow study procedures, and those currently participating in another clinical trial are excluded.
Study focus: The trial will monitor changes in bone density, HbA1c levels, and other markers related to bone and metabolic health. Regular check-ups will assess the medication’s effects on both bone health and blood sugar control in diabetic patients.
Investigational drug: Alendronate is a bisphosphonate medication that works by slowing down the process that breaks down bone tissue, helping to maintain or increase bone density. In this trial, researchers are examining how it might influence both bone health and blood sugar control.
Study on the Effects of Stopping Alendronic Acid in Patients with Osteoporosis
The ALEXIS study investigates what happens when patients who have been taking alendronic acid for a long time stop this medication. This three-year study will help determine whether it is safe to discontinue treatment after long-term use and how it impacts bone health.
Who can participate: This trial is only open to postmenopausal women aged between 55 and 80 years who are currently taking alendronate. Eligible participants must have been on alendronate for more than 3 years without any fractures, or for more than 5 years with the last low-energy fracture occurring over 3 years ago.
Who cannot participate: Men, individuals who do not have osteoporosis, people outside the specified age range, and those considered part of vulnerable populations cannot participate.
Study focus: Participants will be randomly assigned to either continue or stop taking alendronate. The study will monitor the occurrence of bone fractures, changes in bone density at the spine and hip, and bone turnover markers. Safety monitoring will track any side effects experienced by participants.
Investigational drug: Alendronate is used to strengthen bones and reduce fracture risk. This study focuses on understanding what happens to fracture risk and bone health when patients stop taking this medication after long-term use.
Study on the Use of Romosozumab and Zoledronic Acid for Treating Osteoporosis in Patients
The OPTIMIST study explores the best way to use romosozumab for treating osteoporosis by testing three different treatment strategies. The study will examine how these treatments affect bone density and other aspects of bone health over time.
Who can participate: Only postmenopausal women with osteoporosis can participate. Eligible participants must have either a bone density T-score of less than -2.5 at the spine, total hip, or femoral neck, or have had an osteoporotic fracture in the spine, hip, pelvis, forearm, or upper arm within the last 3 years after turning 50 years old.
Who cannot participate: Men, individuals not within the specified age range, and people considered part of vulnerable populations are excluded.
Study focus: The 52-week study will evaluate changes in bone density at the hip, spine, and femoral neck over 24 months. Additional assessments will include bone microarchitecture, bone turnover markers, and bone biopsies to evaluate bone health and response to treatment.
Investigational drugs: Romosozumab works by helping to build new bone and increase bone strength, given as a monthly injection. Zoledronic acid may also be used in the study, administered as an intravenous infusion. The study aims to determine the most effective approach for using these medications.
Study on Zoledronic Acid Following Denosumab for Osteoporosis Patients
This trial examines whether zoledronic acid can help prevent bone loss in patients who have previously been treated with denosumab. The study will explore whether multiple infusions of zoledronic acid given at different times after stopping denosumab can maintain bone health.
Who can participate: Only postmenopausal women aged 40 years or older can participate. Eligible participants must have been treated with denosumab for at least two years, with the last injection received less than five months ago. They must also have at least two lumbar vertebrae that can be evaluated by bone density scanning.
Who cannot participate: Men and people considered part of vulnerable populations cannot participate.
Study focus: The study will monitor bone density changes at the lumbar spine, total hip, and femoral neck after 12 and 36 months. It will also examine how stopping denosumab affects muscle mass, muscle strength, and insulin sensitivity. Participants will receive yearly infusions of zoledronic acid to help maintain bone health after the initial treatment period.
Investigational drugs: Zoledronic acid is given as an intravenous infusion to prevent bone loss by slowing down bone breakdown. Denosumab, the medication patients were taking before the trial, works by slowing the process that breaks down bone, helping to maintain bone density and strength.
Study Comparing MAB-22 and Denosumab for Treating Osteoporosis in Postmenopausal Women
This trial compares two treatments containing denosumab: MAB-22 and Prolia. The study aims to determine if MAB-22 works as well as Prolia in treating osteoporosis in postmenopausal women.
Who can participate: Participants must be postmenopausal women aged between 55 and 80 years with osteoporosis, defined by bone density measurements showing a T-score less than -2.5. Body weight must be between 50 kg and 90 kg. Participants must have at least 3 vertebrae in the lower spine and at least one hip that can be checked by bone density scanning. Various blood tests must show adequate organ function, including normal liver enzymes, kidney function, and calcium levels.
Who cannot participate: Men, individuals who are not postmenopausal women, people without osteoporosis, and those considered part of vulnerable populations are excluded.
Study focus: The 18-month study will monitor bone mineral density changes and blood markers related to bone health. Participants will receive either MAB-22 or Prolia through subcutaneous injection every six months. Regular assessments will evaluate bone health and any side effects or immune responses to the medication.
Investigational drugs: MAB-22 is being tested to see if it works similarly to Prolia in improving bone mineral density. Prolia is an established medication used in the European Union to treat osteoporosis in postmenopausal women by increasing bone density and reducing fracture risk.
Study on Dasatinib and Quercetin or Nicotinamide Riboside for Patients with Osteoporosis or Osteopenia
This 20-week trial investigates the effectiveness and safety of combining dasatinib with either quercetin or nicotinamide riboside in reducing bone loss in patients with low bone mass.
Who can participate: Men and women aged 60-90 years can participate. Women must be more than 5 years past menopause with hormone levels in the postmenopausal range. Participants need to have a T-score less than -1 at the total hip, femoral neck, or lumbar spine, indicating low bone mass. All participants must be able to provide informed consent.
Who cannot participate: People with a history of severe allergic reactions to the study medications, those taking medications that could interfere with the study drugs, individuals with serious heart conditions, severe liver or kidney disease, pregnant or breastfeeding women, those who participated in another clinical trial within the last 30 days, and anyone with other medical conditions deemed unsafe by study doctors are excluded.
Study focus: The study will monitor markers of bone resorption, particularly CTX, and markers of bone formation throughout the 20-week period. Regular blood tests and assessments will measure the medication’s impact on bone health.
Investigational drugs: Dasatinib is being studied for its potential to reduce bone breakdown. Quercetin, a natural substance, and nicotinamide riboside, a form of vitamin B3, are both being tested for their properties that might help protect bones and support bone strength when combined with dasatinib.
Study on Zoledronic Acid for Healing After Rotator Cuff Surgery in Patients with Tendon Rupture and Osteoporosis
This trial examines whether zoledronic acid can improve tendon healing after arthroscopic surgery for chronic rotator cuff tears in patients who also have osteoporosis. The study will monitor healing using MRI scans over a period of up to five years.
Who can participate: Eligible participants must be between 50 and 70 years old with a confirmed rotator cuff tear shown by MRI within 6 months before surgery. The tear should not be larger than 3 cm in diameter. Participants must be willing to participate in the study and follow a specific physiotherapy program, including using a shoulder abduction pad for four weeks after surgery.
Who cannot participate: Patients with a history of trauma specifically involving a tendon rupture and patients with osteoporosis are excluded.
Study focus: The study will use MRI scans at six, twelve, twenty-four, and sixty months post-surgery to evaluate tendon integrity and check for any re-rupture. Additional evaluations will measure fatty muscle infiltration, shoulder movements, strength, and pain levels using various assessment scores.
Investigational drug: Zoledronic acid is given through intravenous infusion to see if it helps improve tendon healing after surgery. The medication works by inhibiting bone breakdown and is being studied for its potential positive effects on tendon repair.
Study on the Effectiveness and Safety of LY06006 and Denosumab for Postmenopausal Women with Osteoporosis
This trial compares LY06006 and EU-Prolia, both containing the active substance denosumab, to determine if LY06006 is as effective and safe as EU-Prolia in treating postmenopausal osteoporosis.
Who can participate: Participants must be postmenopausal women between 55 and 90 years old (up to 75 in Czech Republic). They must not have had a menstrual period for at least 12 months, confirmed by blood test in Bulgaria. Participants need a diagnosis of osteoporosis with a T-score between -2.5 and -4.0 at the lower spine, at least two lower spine bones and one hip measurable for bone density, and body weight between 50 kg and 90 kg. All participants must be able to read, understand, and sign an informed consent form.
Who cannot participate: Men, individuals outside the specified age range, people without postmenopausal osteoporosis, and those considered part of vulnerable populations cannot participate.
Study focus: The approximately 18-month study will include regular check-ups to monitor bone health and overall well-being through blood tests and bone density scans. Follow-up assessments at various intervals will measure bone density, blood markers for bone health, and monitor for any adverse effects or immune responses to the medication.
Investigational drugs: LY06006 is being studied to show it works as well as EU-Prolia in improving bone health. EU-Prolia is an established medication used to increase bone mineral density and reduce fracture risk in postmenopausal women with osteoporosis. Both medications are administered via subcutaneous injection.
Summary
The nine ongoing clinical trials for osteoporosis demonstrate a diverse approach to bone health management, with a notable concentration of research in Denmark, which hosts six of the nine trials. The studies investigate several different types of medications, including bisphosphonates such as alendronate and zoledronic acid, bone-building treatments like romosozumab, and denosumab-based therapies including biosimilar comparisons.
Several trials focus on specific patient populations, including postmenopausal women, patients with diabetes, and those previously treated with denosumab. Innovative approaches are also being explored, such as the combination of dasatinib with quercetin or nicotinamide riboside, and an Austrian study examining zoledronic acid’s effects on tendon healing after rotator cuff surgery in patients with osteoporosis.
Three trials are being conducted in multiple countries, with Bulgaria, Czechia, and Poland participating in studies comparing biosimilar medications to established denosumab treatments. These international trials reflect efforts to expand treatment options and ensure the availability of effective medications across different healthcare systems.
