Romosozumab for Patients with Multiple Myeloma with Skeletal Events on Zoledronic Acid: A Pilot Study
- Conditions
- Multiple myelomaCancer - Myeloma
- Registration Number
- ACTRN12624000027516
- Lead Sponsor
- St Vincent's Hospital, Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Males or females with multiple myeloma
Age 18 years or older.
Skeletal related event with at least 3 doses of anti-resorptive therapy
Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
History of myocardial infarction or stroke in prior 12 months
Women of child bearing potential
Active unstable cardiovascular function
Previous teriparatide or any parathyroid hormone (PTH) analogs
History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget’s disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia and malabsorption syndrome
Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 50nmol/L. Vitamin D repletion will be permitted and subjects may be rescreened
Current hyper- or hypocalcemia
Current, uncontrolled hyper- or hypothyroidism
Current, uncontrolled hyper- or hypoparathyroidism,
History of dental extraction or other invasive dental work within 3 years, or who require invasive dental work within the next two years or history of osteonecrosis of the jaw
Life expectancy of less than 2 years.
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method