Postmenopausal Osteoporosis MedDRA version: 8.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Trade Name: Protelos
Product Name: strontium ranelate
Product Code: n/a
Pharmaceutical Form: Oral suspension
Sponsors
R+ D department, Hull and East Yorkshire NHS Hospital Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) - Age: 50-75 2) - T score: 1 year treatment with oral bisphosphonates and stopped treatment within the last 1 month due to lack of effect or side effects. Also if treated with pamidronate for > 1 year and last infusion within the last 3 month. (to allow clear distinction between the study groups) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Significant renal disease. (creatinine clearance < 30 ml/min) Prior treatment with Strontium Ranelate. Active malignancy Osteomalacia Primary hyperparathyroidism Patient is unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessing whether previous treatment of osteoporosis with a bisphosphonates affects the subsequent response to treatment with Strontium Ranelate. ; Secondary Objective: Assessment of the relative merits of different established techniques for monitoring the response of osteoporotic patients to Strontium Ranelate. ; Primary end point(s): The change from baseline in bone mineral density at 1 year will be compared between the 2 groups. At the end of the first year subjects will be offered the chance to enter into the second year of the study. Informed consent will be taken for the second year. The drug treatment will remain the same but there will be 2 extra vists at 18 and 24 months. The end point for this extention will be bone mineral density at year 2 compared between the 2 groups. | — |
Countries
United Kingdom
Outcome results
None listed