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NCT01679080
The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
Phase 2 trial testing Zoledronic acid in Osteogenesis Imperfecta in 9 participants. Terminated before completion.
1 July 2020
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 1 November 2012 |
| Primary completion | 1 July 2020 |
| Estimated completion | 1 June 2021 |
| Sites | 3 locations across Denmark |
Drugs / interventions tested
- Zoledronic acid (ZOLEDRONIC ACID) — full drug profile →
- Teriparatide — full drug profile →
- No active treatment
Conditions studied
- Osteogenesis Imperfecta — all drugs for Osteogenesis Imperfecta →
Sponsor
University of Aarhus
Who can join
Adults 22 to 70, any sex, with Osteogenesis Imperfecta. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Collagen transport and related pathways in Osteogenesis Imperfecta.
Claeys L, Storoni S, Eekhoff M, Elting M, et al · · 2021 · cited 67× · PMID 34169326 · DOI 10.1007/s00439-021-02302-2
Verify or expand the search:
- PubMed search for NCT01679080
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT05866172 — HAIC Combined Withzoledronic Acid for the Prevention of Bone Metastases in Advanced HCC · Phase 3 · unknown
- NCT06051344 — Effect of Zoledronic Acid in Primary Knee Osteoarthritis · Phase 4 · unknown
- NCT05405894 — Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation · unknown
Other recruiting trials for Osteogenesis Imperfecta
Currently open trials in the same condition.
- NCT07366086 — Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta · Phase 3 · recruiting
- NCT07412782 — REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD) · NA · recruiting
- NCT05972551 — Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Oste · Phase 3 · recruiting
- NCT05927389 — Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Osteogenesis Imperfecta · NA · recruiting
- NCT06193642 — Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data · NA · active not recruiting
Other University of Aarhus trials
Trials by the same sponsor.
- NCT07209540 — European LUpuS Inception-Cohort Developing initiATivE · not yet recruiting
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- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01679080 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 22 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01679080.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing