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

Primary Purpose

Primary Hyperparathyroidism, Osteopenia, Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Strontium Ranelate + Ca/Vitamin-D
Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hyperparathyroidism focused on measuring Primary Hyperparathyroidism, Osteopenia, Osteoporosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University Vienna, General Hospital Vienna (AKH Wien)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Strontium Ranelate

Placebo

Arm Description

Receiving Strontium Ranelate + Ca/Vitamin-D

Receiving Placebo + Ca/Vitamin D

Outcomes

Primary Outcome Measures

Bone mineral density measurement of the Lumbar spine

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2010
Last Updated
January 16, 2015
Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria
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1. Study Identification

Unique Protocol Identification Number
NCT01222026
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism, Osteopenia, Osteoporosis
Keywords
Primary Hyperparathyroidism, Osteopenia, Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strontium Ranelate
Arm Type
Active Comparator
Arm Description
Receiving Strontium Ranelate + Ca/Vitamin-D
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Receiving Placebo + Ca/Vitamin D
Intervention Type
Drug
Intervention Name(s)
Strontium Ranelate + Ca/Vitamin-D
Other Intervention Name(s)
Protelos (r)
Intervention Description
2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1000mg Calcium 800 IE Vitamin-D
Primary Outcome Measure Information:
Title
Bone mineral density measurement of the Lumbar spine
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bone mineral density of the femoral neck
Time Frame
1 year
Title
Bone mineral density of the radius
Time Frame
1 year
Title
Osteoprotegerin (OPG/OCIF)
Time Frame
1 year
Title
RANKL (OPG-ligand)
Time Frame
1 year
Title
cathepsin K (cat K)
Time Frame
1 year
Title
ionised calcium (Ca++)
Time Frame
1 year
Title
phosphate (PO4-)
Time Frame
1 year
Title
alkaline phosphatase (AP)
Time Frame
1 year
Title
bone-specific alkaline phosphatase (BAP)
Time Frame
1 year
Title
osteocalcin (Oc)
Time Frame
1 year
Title
parathyroid hormone (PTH)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Niederle, Prof., MD
Organizational Affiliation
Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna, General Hospital Vienna (AKH Wien)
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

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