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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222026
• Other study ID #: EK Nr 214/2008
• Secondary ID: 2008-001703-32
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2010
• Last updated: January 16, 2015
• Start date: September 2010
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Osteopenia
• Osteoporosis
• Primary Hyperparathyroidism

Intervention

Drug:
• Strontium Ranelate + Ca/Vitamin-D
2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D
• Placebo
Placebo 1000mg Calcium 800 IE Vitamin-D

Locations

Country	Name	City	State
Austria	Medical University Vienna, General Hospital Vienna (AKH Wien)	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	National Bank of Austria

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density measurement of the Lumbar spine		1 year	No
Secondary	Bone mineral density of the femoral neck		1 year	No
Secondary	Bone mineral density of the radius		1 year	No
Secondary	Osteoprotegerin (OPG/OCIF)		1 year	No
Secondary	RANKL (OPG-ligand)		1 year	No
Secondary	cathepsin K (cat K)		1 year	No
Secondary	ionised calcium (Ca++)		1 year	No
Secondary	phosphate (PO4-)		1 year	No
Secondary	alkaline phosphatase (AP)		1 year	No
Secondary	bone-specific alkaline phosphatase (BAP)		1 year	No
Secondary	osteocalcin (Oc)		1 year	No
Secondary	parathyroid hormone (PTH)		1 year	No