The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
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ClinicalTrials.gov Identifier: NCT01679080 |
Recruitment Status :
Terminated
(Eli Lilly has withdrawn support to the study of teriparatide and placebo pens. The study was not able to continue as a randomized study without the supply of placebo pens.)
First Posted : September 5, 2012
Last Update Posted : June 25, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
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Osteogenesis Imperfecta | Drug: Zoledronic acid Drug: Teriparatide Other: No active treatment | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | July 1, 2020 |
Actual Study Completion Date : | June 1, 2021 |

Arm | Intervention/treatment |
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Experimental: Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
yearly intravenous infusion of 5mg active zoledronic acid in 3 yr
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Drug: Zoledronic acid
antiresorptive and calcium and vitamin D
Other Names:
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Experimental: teriparatide 2 yr; active zol in 3rd yr
daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
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Drug: Zoledronic acid
antiresorptive and calcium and vitamin D
Other Names:
Drug: Teriparatide anabolic and calcium and vitamin D
Other Names:
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Placebo Comparator: No active treatment
Observation in three years, no treatment
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Other: No active treatment
Calcium and vitamin D |
- 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.
- 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.

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Ages Eligible for Study: | 22 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679080
Denmark | |
Osteoporosis clinic; department of endocrinology and metabolism | |
Aarhus, Aarhus C, Denmark, 8000 | |
Department of endocrinology | |
Hvidovre, Denmark, 2650 | |
Department of Endocrinology M | |
Odense, Denmark, 6000 |
Principal Investigator: | Bente Langdahl, MD | Aarhus University Hospital |
Responsible Party: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT01679080 |
Other Study ID Numbers: |
TreatOI |
First Posted: | September 5, 2012 Key Record Dates |
Last Update Posted: | June 25, 2021 |
Last Verified: | June 2021 |
Drug therapy Adult |
Osteogenesis Imperfecta Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Genetic Diseases, Inborn Collagen Diseases |
Connective Tissue Diseases Zoledronic Acid Teriparatide Bone Density Conservation Agents Physiological Effects of Drugs Calcium-Regulating Hormones and Agents |