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Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate

Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium- and Bone Metabolism After Successful Surgery? - Part I

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01222026
Enrollment
63
Registered
2010-10-18
Start date
2010-09-30
Completion date
2014-12-31
Last updated
2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia, Osteoporosis, Primary Hyperparathyroidism

Keywords

Primary Hyperparathyroidism, Osteopenia, Osteoporosis

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.

Interventions

DRUGStrontium Ranelate + Ca/Vitamin-D

2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D

DRUGPlacebo

Placebo 1000mg Calcium 800 IE Vitamin-D

Sponsors

National Bank of Austria
CollaboratorOTHER_GOV
Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Bone mineral density measurement of the Lumbar spine1 year

Secondary

MeasureTime frame
Bone mineral density of the radius1 year
Osteoprotegerin (OPG/OCIF)1 year
RANKL (OPG-ligand)1 year
cathepsin K (cat K)1 year
ionised calcium (Ca++)1 year
Bone mineral density of the femoral neck1 year
alkaline phosphatase (AP)1 year
bone-specific alkaline phosphatase (BAP)1 year
osteocalcin (Oc)1 year
parathyroid hormone (PTH)1 year
phosphate (PO4-)1 year

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026