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NCT01679080·Phase 2·INTERVENTIONAL

The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

TeriparatideOtherTerminated

Status

Terminated

Phase

Phase 2

Enrollment

9

Locations

3

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the present study is to investigate the effect of treatment of adult OI patients with bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture risk and quality of life. The investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.

Interventions

Treatment arms and agents.

DRUG

Zoledronic acid

antiresorptive and calcium and vitamin D

DRUG

Teriparatide

anabolic and calcium and vitamin D

OTHER

No active treatment

Calcium and vitamin D

Timeline

From registration to results.

  1. First posted

    Sep 5, 2012

  2. Study start

    Nov 2012

  3. Primary completion

    Jul 1, 2020

  4. Study completion

    Jun 1, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Jun 25, 2021

Outcomes

What the study measures.

Primary outcomes

Bone Mineral Density (BMD)

Time frame · Three years

Dual-energy X-ray absorptiometry scans are performed at the lumbar spine, hip and whole body twice yearly. The value of the lumbar BMD is the primary outcome.

Secondary outcomes

Fracture risk

Time frame · Three years

Participants are asked to report fractures throughout the study. Medical examination yearly with a focus on possible new fractures. Columnar x-ray before and after the study investigate new fractures.

Eligibility

Who can take part.

Minimum age
22 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * clinical diagnosis of osteogenesis imperfecta * BMD\<-1.0 or Exclusion Criteria: * creatinine clearance \<30mL/min * treatment with glucocorticoids \> 5mg daily during the last 3 months * metabolic bone disease or vitamin d deficiency * liver or kidney disease * contradictions to zoledronic acid or teriparatide * increased baseline risk of osteosarcoma

Study locations

3 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

Osteoporosis clinic; department of endocrinology and metabolism

Aarhus, Aarhus C, Denmark

Department of endocrinology

Hvidovre, Denmark

Department of Endocrinology M

Odense, Denmark

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsTeriparatide trial dashboard →DatabaseTeriparatide database entry →ResearchTeriparatide research guide →