Zoledronate Early to Hip Fracture Patients - Safe and Effective?
Launched by LENE BERGENDAL SOLBERG · Aug 23, 2021
Trial Information
Current as of June 07, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at the best timing for giving a medication called zoledronate to patients who have just had surgery for a hip fracture. Zoledronate is used to help prevent further fractures in people with weak bones, a condition known as osteoporosis. The study will compare giving zoledronate within 5 days after hip surgery to giving it 3 months later to see which timing is more effective and safe.
To participate in the trial, you need to be over 50 years old and have experienced a low-energy hip fracture that required surgery within 72 hours. You should also have good kidney function and calcium levels. Participants will be monitored throughout the study and will need to provide consent to join. This trial is currently recruiting participants, and everyone involved, including the doctors and patients, won't know who is receiving the actual medication and who is getting a placebo (a harmless substance). This helps ensure the results are reliable. If you're considering this trial, it’s a great opportunity to contribute to research that could improve care for future hip fracture patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Low energy hip fracture
- • Surgery within 72 hours
- • \>50 years old norwegian
- • Women age 50-60 must be postmenopausal or not pregnant
- • Acceptable kidney function (estimated GFR \>=35) and calcium levels
- • Fit to complete the follow-up judged by the recruiting physician
- • Signed informed consent by the patient or the next of kin
- Exclusion Criteria:
- • Metal in the opposite hip
- • Anti-osteoporosis treatment with bisphosphonates, denosumab, teriparatide, abaloparatide or romosozumab within the last 10 years
- • Glucocorticoid therapy
- • Too sick to receive treatment with zoledronate judged by the recruiting or treating physician
- • Any other contraindication listed on the SmPC of the IMP(s) including pregnancy
- • Participating in another trial that might affect the current study
About Lene Bergendal Solberg
Lene Bergendal Solberg is a dedicated clinical trial sponsor with a focus on advancing medical research and innovation. With a commitment to improving patient outcomes, she oversees the development and execution of rigorous clinical studies that adhere to the highest ethical standards and regulatory requirements. Her expertise spans various therapeutic areas, ensuring that each trial is designed to yield meaningful results that contribute to the scientific community and enhance treatment options for patients. Through collaborative partnerships and a patient-centered approach, Lene Bergendal Solberg aims to drive progress in healthcare and foster advancements in therapeutic solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oslo, , Norway
Patients applied
Trial Officials
Solberg B Lene, PhD MD
Principal Investigator
Oslo University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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