This trial is active, not recruiting.

Conditions primary hyperparathyroidism, osteopenia, osteoporosis
Treatments strontium ranelate + ca/vitamin-d, placebo
Phase phase 4
Sponsor Medical University of Vienna
Collaborator National Bank of Austria
Start date September 2010
End date December 2014
Trial size 60 participants
Trial identifier NCT01222026, 2008-001703-32, EK Nr 214/2008


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
Receiving Strontium Ranelate + Ca/Vitamin-D
strontium ranelate + ca/vitamin-d Protelos (r)
2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D
(Placebo Comparator)
Receiving Placebo + Ca/Vitamin D
placebo Placebo
Placebo 1000mg Calcium 800 IE Vitamin-D

Primary Outcomes

Bone mineral density measurement of the Lumbar spine
time frame: 1 year

Secondary Outcomes

Bone mineral density of the femoral neck
time frame: 1 year
Bone mineral density of the radius
time frame: 1 year
Osteoprotegerin (OPG/OCIF)
time frame: 1 year
RANKL (OPG-ligand)
time frame: 1 year
cathepsin K (cat K)
time frame: 1 year
ionised calcium (Ca++)
time frame: 1 year
phosphate (PO4-)
time frame: 1 year
alkaline phosphatase (AP)
time frame: 1 year
bone-specific alkaline phosphatase (BAP)
time frame: 1 year
osteocalcin (Oc)
time frame: 1 year
parathyroid hormone (PTH)
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - biochemically proven PHPT, PTX planned - osteopenia (t-score < -1 and > -2.5) or osteoporosis (t-score ≤ -2.5) according to WHO Criteria [27] Exclusion Criteria: - 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

Additional Information

Official title Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I
Principal investigator Bruno Niederle, Prof., MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Medical University of Vienna.