EUCTR2005-003138-16-GB
Active, not recruiting
Phase 1
A clinical observational study to assess the effectiveness of Strontium Ranelate on bone protection in osteoporotic patients pre-treated with bisphosphonates. - Strontium following bisphosphonate therapy
R+ D department, Hull and East Yorkshire NHS Hospital Trust0 sites0 target enrollmentJuly 25, 2005
ConditionsPostmenopausal OsteoporosisMedDRA version: 8.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
DrugsProtelos
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Postmenopausal Osteoporosis
- Sponsor
- R+ D department, Hull and East Yorkshire NHS Hospital Trust
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) \- Age: 50\-75
- •2\) \- T score: \<\-2\.5 at either hip or spine or a T score \<2\.0 and one BMD independent risk factor for fracture (previous osteoporotic fracture, maternal osteoporotic fracture, previous steroid use, BMI \<19, untreated premature menopause) (typical criteria for patients considered as requiring treatment to reduced their risk of fracture).
- •3\)\-Fit into group 1 or 2 below:
- •Group1: no previous bisphosphonates.
- •Group 2: \> 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
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
Outcomes
Primary Outcomes
Not specified
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