Bone Health in Duchenne Muscular Dystrophy- a case controlled study of Risedronate use - Risedronate in DMD
- Conditions
- Bone Health in Duchenne Muscular Dystrophy- a randomised controlled study of Risedronate use
- Registration Number
- EUCTR2009-017649-67-IE
- Lead Sponsor
- The Central Remedial Clinic and The Children's University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 70
1.>/4 years old at time of initiation of study
2. Z score as measured by DXA >1.0 S.D. below the mean
3. boys only with DMD
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range
1. Hypersensitivity to Risedronate sodium
2. <4years at time of initiation of study
3. Previous bisphosphonate use
4. Uncorrected hypocalcaemia, uncorrected low Vitamin D
5. Inability to stay in an upright position (sitting or standing) for at least 30minutes
6. Severe renal impairment (creatinine clearance <30ml/min)
7.Undergoing invasive dental treatment
8. History of recent or active oesophageal or upper gastrointestinal problems
9.History of oesophageal disorders which delay oesophageal transit or emptying e.g. stricture or achalasia
10. Involvement in clinical trial in the preceding 12 weeks.
11. Learning difficulties in carer resulting in difficulties comprehending treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method