Clinical trial NCT01222026: Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate
Official title: Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Hyperparathyroidism
Osteopenia
Osteoporosis
Keywords: Primary Hyperparathyroidism
Osteopenia
Osteoporosis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: National Bank of Austria
First posted: 2010-10-18
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone mineral density measurement of the Lumbar spine
timeFrame: 1 year
Secondary outcomes:
measure: Bone mineral density of the femoral neck
timeFrame: 1 year
measure: Bone mineral density of the radius
timeFrame: 1 year
measure: Osteoprotegerin (OPG/OCIF)
timeFrame: 1 year
measure: RANKL (OPG-ligand)
timeFrame: 1 year
measure: cathepsin K (cat K)
timeFrame: 1 year
measure: ionised calcium (Ca++)
timeFrame: 1 year
measure: phosphate (PO4-)
timeFrame: 1 year
measure: alkaline phosphatase (AP)
timeFrame: 1 year
measure: bone-specific alkaline phosphatase (BAP)
timeFrame: 1 year
measure: osteocalcin (Oc)
timeFrame: 1 year
measure: parathyroid hormone (PTH)
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, General Hospital Vienna (AKH Wien)
Study officials:
affiliation: Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna
name: Bruno Niederle, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: