In short
There are currently 3 clinical trials investigating new treatments for postmenopausal osteoporosis across Europe. These studies are testing medications designed to strengthen bones and reduce fracture risk in women who have gone through menopause and developed weakened bones due to hormonal changes.
Clinical trial locations
- Bulgaria
- Denmark
- Estonia
- France
- Hungary
- Latvia
- Poland
- Slovakia
Study on the Effects of AGA2118 for Postmenopausal Women with Osteoporosis
This trial is testing a new medication called AGA2118, which is a type of monoclonal antibody given as an injection under the skin. The study aims to evaluate whether this treatment can safely and effectively increase bone mineral density in postmenopausal women with low bone mass.
Who can participate: The study is looking for healthy, ambulatory postmenopausal women aged between 55 and 80 years who have a bone mineral density T-score between -2.5 and -3.5 at the lumbar spine, total hip, or femoral neck. Participants must be able to walk without assistance and be in generally good health.
Who cannot participate: Men are excluded from this study. Women who are not postmenopausal or do not have low bone mineral density cannot participate. Additionally, individuals who are part of vulnerable populations, such as those with certain disabilities requiring special protection, are not eligible.
What the study focuses on: The main goal is to measure changes in bone mineral density at the lumbar spine after 12 months of treatment. The study will also monitor bone density at other sites like the hip and forearm, and track any new bone fractures. Participants will receive regular injections and undergo bone density measurements throughout the 12-month study period. Some participants will receive the active medication while others will receive a placebo.
Investigational drug: AGA2118 is designed to improve bone mineral density by targeting specific pathways involved in bone metabolism. It aims to enhance bone strength and reduce fracture risk in women with weakened bones after menopause.
Study on Zoledronic Acid Use After Stopping Denosumab in Women with Postmenopausal Osteoporosis
This study examines the best way to maintain bone health after stopping denosumab treatment. It compares two different strategies for using zoledronic acid: one based on specific biological markers in the body and another following a standard treatment plan.
Who can participate: Women aged 18 years or older with postmenopausal osteoporosis who have been treated with denosumab for at least two years are eligible. Participants must have reached their treatment goals, meaning they have not had fractures during treatment, have no new risk factors, and their bone mineral density has remained stable. They must also provide written informed consent and be affiliated with the French social security scheme.
Who cannot participate: Women who have not been previously treated with denosumab are excluded. Patients with other bone diseases besides osteoporosis, severe kidney problems, or those taking other medications affecting bone health cannot participate. Those with a history of allergic reactions to zoledronic acid, who are pregnant or breastfeeding, or have serious medical conditions that could interfere with the study are also ineligible.
What the study focuses on: The trial lasts one year and monitors bone health using dual-energy X-ray absorptiometry scans. The primary goal is to determine the proportion of participants who maintain their bone mineral density at the lumbar spine after one year. The study also tracks changes in bone turnover markers, the occurrence of new fractures, and any adverse events.
Investigational drugs: Zoledronic acid is given as an intravenous infusion and works by slowing down bone breakdown, helping to maintain bone strength and prevent fractures. The study examines how to best use this medication after stopping denosumab, which was previously used to increase bone mass and strength.
Study on the Effects of BP16 and Denosumab in Women with Post-Menopausal Osteoporosis
This trial compares the effects of a new medication called BP16 with an established treatment known as EU-Prolia. The study aims to determine whether BP16 is as effective and safe as EU-Prolia in treating postmenopausal osteoporosis.
Who can participate: Postmenopausal women aged between 55 and 80 years with evidence of osteoporosis are eligible. Participants must have a bone mineral density T-score between -2.5 and -4.0 at the lumbar spine, weigh between 50 and 90 kg, and have at least three intact vertebrae in the lower spine that can be properly evaluated. Written informed consent is required before any study procedures begin.
Who cannot participate: Men cannot participate in this study. Women who are not postmenopausal are excluded. Individuals considered part of vulnerable populations, such as children, pregnant women, or people with certain disabilities who might need extra protection in research, are not eligible.
What the study focuses on: The trial lasts approximately one year and involves regular check-ups to monitor bone health. Participants receive either BP16 or EU-Prolia through subcutaneous injection, along with vitamin D3 and calcium carbonate to support bone health. The study measures changes in bone mineral density and bone turnover markers at specified intervals, including at weeks 26, 52, and 78. Safety is monitored throughout the study period.
Investigational drugs: BP16 is a monoclonal antibody designed to inhibit proteins involved in bone breakdown, helping to maintain bone density. EU-Prolia works similarly by targeting proteins that cause bone loss, thereby preserving bone density and reducing fracture risk. Both medications are given as injections under the skin.
Summary
The three ongoing clinical trials for postmenopausal osteoporosis are spread across multiple European countries, with notable concentration in Eastern European nations such as Bulgaria, Estonia, and Poland. Each study takes a different approach to strengthening bones and preventing fractures in postmenopausal women.
Two trials are investigating new experimental medications: AGA2118 and BP16, both monoclonal antibodies designed to target specific pathways in bone metabolism. The third trial focuses on optimizing the use of zoledronic acid, an established treatment, specifically in patients transitioning from denosumab therapy.
All three studies emphasize the importance of bone mineral density measurements and careful monitoring for fractures and side effects. They are designed exclusively for postmenopausal women, reflecting the specific hormonal changes that lead to bone loss after menopause. The trials range from one to two years in duration and use various methods of drug administration, including subcutaneous injections and intravenous infusions.
These studies represent important efforts to expand treatment options and improve care strategies for women living with postmenopausal osteoporosis, a condition that significantly increases the risk of debilitating fractures.
