Osteoporosis MedDRA version: 13.1 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 13.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Protelos
Product Name: PROTELOS
Pharmaceutical Form: Granules for oral suspension
Other descriptive name: STRONTIUM RANELATE
Concentration unit: g gram(s)
Concentration type: equal
Sponsors
University Hospitals of Leicester - Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Postmenopausal osteoporosis - women From our local osteoporosis clinics, physicians offer Protelos accordingly, to subjects who require this medication. We simply wish to collect blood and urine samples from subjects who have been directed to take this medication for their osteoporosis. These patients would be monitored for any adverse events by their routine care physicians. 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: Renal failure CKD stage 4 or more Thromboembolism - History of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To look at interferences strontium may produce in the measurement of other minerals such as magnesium, calcium, zinc, copper and iron, which are routinely measured.;Secondary Objective: 1. To see how quickly and to what level serum strontium levels stabilise. 2. To look at correlations between serum and urinary strontium levels and bone mineral density at 1 and 2 year periods. 3. To look at variation in serum and urinary strontium levels with variations in renal function, eGFR, in subjects with normal renal function. 4. Correlations between serum and urinary strontium levels and biomarkers of bone turnover; serum BALP and CTX, urine NTX, DPD/Cr.;Primary end point(s): Patients will be monitored as usual, for bone mineral density response and fracture recurrence. For this study, we are simply looking at urine and serum levels and relating them to bone mineral density response. | — |
Countries
United Kingdom
Outcome results
None listed