Osteoporosis and Reduced Bone mineral density (T scores< -1.0 on DEXA scan), Adult growth hormone deficiency ( GH levels,9mU/l on Insulin stress test) with reduced BMD (T scores< -1.0 on DEXA scan)
Conditions
Interventions
Product Name: strontium ranelate
Product Code: strontium ranelate
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: strontium ranel
Sponsors
Royal Liverpool University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Postmenopausal women(no spontaneous menses for 2years or more) >55 years with reduced BMD (T score =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Abnormal PTH, calcium, phosphate, vitamin D (3 times upper limit of normal) •Renal disease (Creatinine > 150µmol/l) •Patients with nephrocalcinosis (renal stone ) •Malignant carcinomas, tumour activity, excluding basal cell carcinoma of skin •Previous vertebral or hip fracture •Ongoing treatment with corticosteroids, bisphosphonates, diuretics, calcium and vitamin D (pharmacological doses) •Women on HRT •Previous venous thromboembolism •Patients with uncontrolled or accelerated hypertension •Patients with Phenylketonuria •Patients who refuse to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of Growth hormone, Strontium therapy,and oral phosphate on a.The pattern of parathyroid hormone secretion over 24 hour period (PTH circadian rhythmicity) b.Effects of parathyroid hormone on kidney and bone (PTH target organ sensitivity) in postmenopausal women and men with reduced bone mineral density, and Adult growth hormone deficient patients. Study endpoints: Difference in PTH circadian rhythmicity, target organ sensitivity and bone turnover in the study groups before and after treatment with Growth hormone,Strontium ranelate and phosphate sandoz administered alone or in combination. ; Secondary Objective: Changes in bone turnover Changes in bone mineral density ; Primary end point(s): the primary endpoints of the study are the differences in PTH circadian rhythmicity, target organ sensitivity and bone turnover, in post menopausal women, elderly men with reduced bone mineral density (BMD) and adult growth hormone deficient (AGHD) patients. The secondary endpoints are the effects on the above parameters of Growth hormone, strontium ranelate and phosphate sandoz in various combinations in these patient groups. | — |
Countries
United Kingdom
Outcome results
None listed