Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life

NCT00730210 | Completed Phase 2 DMC

• 1 other identifier: EudraCT #008-000606-36)
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess whether PTH (1-84) therapy posses advantages compared to conventional treatment in patients with hypoparathyroidism on muscle function, quality of life, calcium homeostasis, bone metabolism, and body composition.

Conditions

Hypoparathyroidism

Keywords

Hypoparathyroidism; HypoPTH; PTH

Outcome Measures

Primary Outcomes (1)

• Increase in maximal voluntary knee extension

  6 months

Secondary Outcomes (8)

• Balance function: Is assessed using a stadiometer (Meititur Ltd, Finland)

  6 months

• Effect of treatment on indices of quality of life is assessed using the SF-36v2- and WHO-Five Well-Being Index (WHO-5)-survey.

  6 months

• Effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, and by biochemical measures (muscle enzymes).

  6 months

• Bone mineral density and body composition is measured

  6 months

• Calcium homeostasis and bone metabolism. Effects of treatment are assessed by measurements of calcitropic hormones, biochemical markers of bone turnover, and bone biopsies

  6 months

Study Arms (2)

a: PTH (1-84) 100 ug s.c.inj. once a day

ACTIVE COMPARATOR

PTH (1-84) 100 ug subcutaneous injections once a day

Drug: a: PTH (1-84)

b: placebo 100 ug s.c. inj. once a day

PLACEBO COMPARATOR

placebo 100 ug sub cutaneous injection once a day

Drug: b:placebo

Interventions

a: PTH (1-84) DRUG

preotact 100 microgram subcutaneous a day in 6 months

Also known as: preotact

a: PTH (1-84) 100 ug s.c.inj. once a day

b:placebo DRUG

100 microgram placebo subcutaneous a day for 6 months

Also known as: Placebo

b: placebo 100 ug s.c. inj. once a day

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A low endogenous PTH production as verified by low plasma levels of intact PTH, necessitating treatment with 1alpha-hydroxylated vitamin D analogs.
• At least one years of continuous alphacalcidol, calcitriol, or dihydrotachysterol treatment prior to study entry.
• Prior to start of study, participants are required to have received a daily supplement of at least 400 IU (10 microgram) of vitamin D (ergocalciferol or cholecalciferol) for at least 3 months or 25hydroxyvitamin D levels above 50 nmol/l. Subjects may be treated with ergocalciferol or cholecalciferol during a run-in period of three months before entering the study.
• Normal plasma magnesium level (If not, magnesium supplements may be provided during a 3 months run in period).
• Plasma calcium levels within the normal reference range or slightly below (P-Ca ionized 1.00 to 1.30).
• Use of safe contraceptive methods (fertile women).
• Speak and read Danish.

You may not qualify if:

• Known allergic reactions to any of the compounds in the trial medication.
• Severely impaired renal function (plasma creatinine \> 200 micromol/l).
• Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) \> 100 U/l and/or alkaline phosphatase \> 400 U/l).
• Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy).
• Prior radiation therapy involving the skeleton.
• Current treatment with raloxifene, calcitonin, systemic corticosteroids above 5 mg a day, fluoride, lithium, PTH, or digoxin.
• Treatment with anticonvulsant's (within the last 2 years).
• Immobilization (more than two week within the last 6 months).
• Granulomatous disease.
• Paget's disease of bone.
• Pregnancy / planned within the next year. Hospitalized due to chronic drug or alcohol abuse. Severe malabsorption syndrome.
• Major medical or social problems that will be likely to preclude participation for one year.
• Unwillingness to participate.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Osteoporoseklinikken, Aarhus University Hospital

Aarhus, Jutland, 8000, Denmark

Location

Related Publications (3)

• Grunewald TA, Liebi M, Wittig NK, Johannes A, Sikjaer T, Rejnmark L, Gao Z, Rosenthal M, Guizar-Sicairos M, Birkedal H, Burghammer M. Mapping the 3D orientation of nanocrystals and nanostructures in human bone: Indications of novel structural features. Sci Adv. 2020 Jun 12;6(24):eaba4171. doi: 10.1126/sciadv.aba4171. eCollection 2020 Jun.

  PMID: 32582855 DERIVED

• Harslof T, Sikjaer T, Sorensen L, Pedersen SB, Mosekilde L, Langdahl BL, Rejnmark L. The Effect of Treatment With PTH on Undercarboxylated Osteocalcin and Energy Metabolism in Hypoparathyroidism. J Clin Endocrinol Metab. 2015 Jul;100(7):2758-62. doi: 10.1210/jc.2015-1477. Epub 2015 May 8.

  PMID: 25955226 DERIVED

• Sikjaer T, Rolighed L, Hess A, Fuglsang-Frederiksen A, Mosekilde L, Rejnmark L. Effects of PTH(1-84) therapy on muscle function and quality of life in hypoparathyroidism: results from a randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1717-26. doi: 10.1007/s00198-014-2677-6. Epub 2014 Apr 1.

  PMID: 24687385 DERIVED

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Lars Rejnmark, MD,DrMed

  PRINCIPAL INVESTIGATOR

• Tanja Sikjær, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 8, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

DK (1)