NCT01222026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

4.3 years

First QC Date

October 15, 2010

Last Update Submit

January 16, 2015

Conditions

Primary HyperparathyroidismOsteopeniaOsteoporosis

Keywords

Primary HyperparathyroidismOsteopeniaOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density measurement of the Lumbar spine

    1 year

Secondary Outcomes (11)

  • Bone mineral density of the femoral neck

    1 year

  • Bone mineral density of the radius

    1 year

  • Osteoprotegerin (OPG/OCIF)

    1 year

  • RANKL (OPG-ligand)

    1 year

  • cathepsin K (cat K)

    1 year

  • +6 more secondary outcomes

Study Arms (2)

Strontium Ranelate

ACTIVE COMPARATOR

Receiving Strontium Ranelate + Ca/Vitamin-D

Drug: Strontium Ranelate + Ca/Vitamin-D

Placebo

PLACEBO COMPARATOR

Receiving Placebo + Ca/Vitamin D

Drug: Placebo

Interventions

Strontium Ranelate + Ca/Vitamin-DDRUG

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

Also known as: Protelos (r)
Strontium Ranelate
PlaceboDRUG

Placebo 1000mg Calcium 800 IE Vitamin-D

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna, General Hospital Vienna (AKH Wien)

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hyperparathyroidism, PrimaryBone Diseases, MetabolicOsteoporosis

Interventions

strontium ranelate

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bruno Niederle, Prof., MD

    Section of Endocrine Surgery, Department of Surgery, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 18, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

AU(1)