Osteogenesis ImperfectaPhase 2NCT01679080
The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
A Phase 2 study testing Zoledronic acid, Teriparatide and No active treatment in people with Osteogenesis Imperfecta, run by University of Aarhus at 3 sites in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Zoledronic acid, Teriparatide and No active treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 3 sitesDenmark
- Study dates
- Nov 2012to 1 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of osteogenesis imperfecta
- BMD<-1.0 or
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Osteoporosis clinic; department of endocrinology and metabolism
Aarhus, Aarhus C, 8000
Department of endocrinology
Hvidovre, 2650
Department of Endocrinology M
Odense, 6000
About this study
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.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Zoledronic acid, Teriparatide, No active treatment
- Keywords
- Drug therapy, Adult
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Also called zolendronate, Aclasta
antiresorptive and calcium and vitamin D
TeriparatideDrug
Also called PTH, Forsteo
anabolic and calcium and vitamin D
No active treatmentOther
Calcium and vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Zolendronic acid, 3 yr + placebo teriparatide, 2 yr | Experimental | yearly intravenous infusion of 5mg active zoledronic acid in 3 yr Receives: Drug: Zoledronic acid |
| teriparatide 2 yr; active zol in 3rd yr | Experimental | daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3. Receives: Drug: Zoledronic acid; Drug: Teriparatide |
| No active treatment | Placebo comparator | Observation in three years, no treatment Receives: Other: No active treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD)
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.
Measured: Three years
Secondary outcomes (1)
Fracture risk
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.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startNov 2012
- Primary completion1 Jul 2020
- Study completion1 Jun 2021
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bente Langdahl, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679080
- Sponsor's protocol ID
- TreatOI
- Status last verified
- Jun 2021
- First submitted
- 16 Aug 2012
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT01679080
- Acronym / sponsor ID
- TreatOI
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Drug therapy, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zolendronic acid, 3 yr + placebo teriparatide, 2 yr | Experimental | Drug: Zoledronic acidyearly intravenous infusion of 5mg active zoledronic acid in 3 yr |
| teriparatide 2 yr; active zol in 3rd yr | Experimental | Drug: Zoledronic acid, Drug: Teriparatidedaily injection of one dose active teriparatide for two years, active zoledronic acid in year 3. |
| No active treatment | Placebo comparator | Other: No active treatmentObservation in three years, no treatment |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of osteogenesis imperfecta
- BMD<-1.0 or
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acidAlso: zolendronate, Aclastaantiresorptive and calcium and vitamin D | Drug | Zolendronic acid, 3 yr + placebo teriparatide, 2 yr, teriparatide 2 yr; active zol in 3rd yr |
| TeriparatideAlso: PTH, Forsteoanabolic and calcium and vitamin D | Drug | teriparatide 2 yr; active zol in 3rd yr |
| No active treatmentCalcium and vitamin D | Other | No active treatment |
Primary outcome
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.
1 secondary outcome
Fracture risk
Time frame: Three years
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente Langdahl, MD principal investigator
Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic acid, Teriparatide and No active treatment in people with Osteogenesis Imperfecta, run by University of Aarhus at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.