Osteoporosis study: Romosozumab vs Zoledronate
Official title The Optimised Use of Romozosumab Study
ClinicalTrials.gov ID: NCT06059222
What this study is testing
What is Romosozumab?
An investigational injectable medicine being studied as a potential treatment for osteoporosis. It is designed to block sclerostin, which helps increase bone formation and bone mineral density.
Also referred to as Evenity.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether splitting up the first medicine works better. It also checks if a shorter course of the first medicine is just as good as the standard plan.
- Who it's for
- You may be able to join if you have osteoporosis (weak bones).
- What's involved
- You would get shots of two different medicines. The team will pick your schedule by chance, like a coin toss.
- Time commitment
- The study lasts two years and needs regular visits to the clinic.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, women only
You may be able to join if
- Postmenopausal women (postmenopausal for at least two years)
- BMD T-score \< -2.5 at lumbar spine, total hip, or femoral neck
- Osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after the age of 50 years.
You likely can't join if
- Osteoporosis treatment including hormone replacement therapy within the last 5 years
- Metabolic bone disease
- Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, liver dysfunction (baseline phosphatase higher than twice upper limit)...
- Ongoing treatment with glucocorticoids (systemic)
- Estimated glomerular filtration rate (eGFR) \< 35 mL/min
- Contraindications for zoledronate according to the Supplementary protection certificates (SPC)
See the full eligibility criteria
- Postmenopausal women (postmenopausal for at least two years)
- BMD T-score \< -2.5 at lumbar spine, total hip, or femoral neck
- Osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after the age of 50 years.
- Osteoporosis treatment including hormone replacement therapy within the last 5 years
- Metabolic bone disease
- Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, liver dysfunction (baseline phosphatase higher than twice upper limit), rheumatism, severe COPD (chronic obstructive pulmonary disease)...
- Ongoing treatment with glucocorticoids (systemic)
- Estimated glomerular filtration rate (eGFR) \< 35 mL/min
- Contraindications for zoledronate according to the Supplementary protection certificates (SPC)
- Contraindications for romosozumab according to the SPC
- For the subgroup with Jamshidi biopsies contraindications for local anaesthetics according to the SPC
- For the subgroup with Jamshidi biopsies contraindications for tetracycline or doxycykline according to the SPC
The study team makes the final eligibility decision.
Where it is enrolling
- Aarhus, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aarhus, Denmark. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.