Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate
- Conditions
- OsteopeniaPrimary HyperparathyroidismOsteoporosis
- Interventions
- Drug: Strontium Ranelate + Ca/Vitamin-DDrug: Placebo
- Registration Number
- NCT01222026
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical treatment of pHPT.
Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.
- Detailed Description
The chronic excessive hypersecretion of parathyroid hormone (PTH) has significant impact on bone remodeling. In primary hyperparathyroidism (PHPT) bone turnover is increased, resulting in a higher resorption of bone and thus loss of bone density.
After successful surgical treatment of pHPT bone metabolism switches from catabolic state to anabolic state again. However studies show that especially postmenopausal women regain significantly less BMD but these women suffer from osteopenia and osteoporosis most often and would need to regain as much bone mass as possible to prevent fractures. The optimal state would be to reach normal BMD again. Although this state is hardly reachable especially these patients may benefit from a treatment acting anti-resorptive and rising bone formation. The only drug combining these qualities known so far is Strontium ranelate.
Therefore the hypothesis is that Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- biochemically proven PHPT, PTX planned
- osteopenia (t-score < -1 and > -2.5) or osteoporosis (t-score ≤ -2.5) according to WHO Criteria [27]
- Premenopausal women
- Cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma >1cm)
- Persisting or recurrent PHPT (postoperative hypercalcemia)
- Four-gland hyperplasia
- Multiple endocrine neoplasia (MEN) or hereditary PHPT
- Familial hypocalciuric hypercalcaemia (Ca/creatinine ratio < 0.01)
- Anamnestic pulmonal embolism or deep venous thrombosis
- Blood coagulation disorder or coagulopathy
- Phenylketonuria
- Renal impairment (creatinine clearance <30ml/h)
- Severe hepatic disorder
- Severe systemic disorder
- Thyroid dysfunction
- Immobilisation
- Intake of drugs with potential effects on BMD like glucocorticoids, lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators (sERMs), bisphosphonates in the last three months
- Known allergy against any component of the study medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Strontium Ranelate Strontium Ranelate + Ca/Vitamin-D Receiving Strontium Ranelate + Ca/Vitamin-D Placebo Placebo Receiving Placebo + Ca/Vitamin D
- Primary Outcome Measures
Name Time Method Bone mineral density measurement of the Lumbar spine 1 year
- Secondary Outcome Measures
Name Time Method Bone mineral density of the femoral neck 1 year ionised calcium (Ca++) 1 year Osteoprotegerin (OPG/OCIF) 1 year RANKL (OPG-ligand) 1 year Bone mineral density of the radius 1 year alkaline phosphatase (AP) 1 year parathyroid hormone (PTH) 1 year cathepsin K (cat K) 1 year bone-specific alkaline phosphatase (BAP) 1 year osteocalcin (Oc) 1 year phosphate (PO4-) 1 year
Trial Locations
- Locations (1)
Medical University Vienna, General Hospital Vienna (AKH Wien)
🇦🇹Vienna, Austria