OsteoporosisPhase 4NCT01360424
Teriparatide Treatment in Patients With Inherited Osteoporosis
A Phase 4 study testing Teriparatide in people with Osteoporosis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Teriparatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFinland
- Study dates
- May 2011to Nov 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inherited low-turnover osteoporosis
- lumbar spine or hip BMD T-score ≤ -2.5
- a written informed consent.
Who cannot join
- age less than 18 years
- generally accepted contraindications for the treatment
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Orthopaedics and Traumatology and Division of Endocrinology, Department of Medicine and Pediatric Endocrinology, Hospital for Children and Adolescents, Helsinki University Central Hospital
Helsinki, FI-00029 HUS
About this study
Official title: Efficacy of Teriparatide Treatment in Patients With New Forms of Inherited Low-Turnover Osteoporosis
The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.
- Conditions
- Osteoporosis
- Being tested
- Teriparatide
- Keywords
- osteoporosis, teriparatide, bone turnover, New forms of inherited low-turnover osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Daily administration of teriparatide 20 ug s.c. for 24 months
| Study group | Role | What they receive |
|---|---|---|
| teriparatide | Experimental | Not described Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in lumbar bone mineral density (BMD)
The primary outcome measure is the change in lumbar BMD measured with dual-energy X-ray absorptiometry (DXA) during the 24 months treatment period.
Measured: 0, 12 and 24 months
Secondary outcomes (9)
Change from baseline in whole body bone mineral density (DXA)
Measured: 0,12 and 24 months
Change from baseline in hip bone mineral density (DXA)
Measured: 0,12 and 24 months
Change from baseline in histomorphometry of bone biopsy samples
includes e.g following parameters: Bone volume (BV/TV, %); Osteoid volume (OV/BV, %); Trabecular thickness (Tb.Th, um); Osteoid surface (OS/BS, %); Osteoblast surface (Ob.S/BS, %); Eroded surface (ES/BS, %); Osteoclast surface (Oc.S/BS, %); Mineral apposition rate (MAR, um/day); Mineralizing surface (MS/BS, %)
Measured: 0 and 24 months
Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples
includes e.g following parameters: bone volume (BV, mm3); relative bone volume (BV/TV, %); connectivity density, (Conn.D., 1/mm3); trabecular number (DT-Tb.N, 1/mm); trabecular thickness (DT-Tb.Th, mm)
Measured: 0 and 24 months
Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius
Measured: 0,12 and 24 months
Number of vertebral fractures (spine X-ray)
Measured: 24 months
Change from baseline in serum procollagen type I N-terminal propeptide (PINP)
Measured: 0,3,6,12 and 24 months
Change from baseline in serum type I collagen C-telopeptides (CTX)
Measured: 0,3,6,12 and 24 months
Change from baseline in serum osteocalcin
Measured: 0,3,6,12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Ville-Valtteri Välimäki, Helsinki University Central Hospital
- Investigators
- Matti Välimäki, MD,PhD, Principal investigator, Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360424
- Sponsor's protocol ID
- HUS-LTO-PTH
- Other IDs
- 2010-019297-32
- Status last verified
- Sep 2015
- First submitted
- 6 May 2011
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Teriparatide Treatment in Patients With New Forms of Inherited Low-Turnover Osteoporosis
- ClinicalTrials.gov ID
- NCT01360424
- Acronym / sponsor ID
- HUS-LTO-PTH
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, teriparatide, bone turnover, New forms of inherited low-turnover osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- May 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 May 2011 (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.
The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| teriparatide | Experimental | Drug: Teriparatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- inherited low-turnover osteoporosis
- lumbar spine or hip BMD T-score ≤ -2.5
- a written informed consent.
Key exclusion criteria (2 listed)
- age less than 18 years
- generally accepted contraindications for the treatment
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 |
|---|---|---|
| TeriparatideDaily administration of teriparatide 20 ug s.c. for 24 months | Drug | teriparatide |
Primary outcome
Change from baseline in lumbar bone mineral density (BMD)
Time frame: 0, 12 and 24 months
The primary outcome measure is the change in lumbar BMD measured with dual-energy X-ray absorptiometry (DXA) during the 24 months treatment period.
9 secondary outcomes
Change from baseline in whole body bone mineral density (DXA)
Time frame: 0,12 and 24 months
Change from baseline in hip bone mineral density (DXA)
Time frame: 0,12 and 24 months
Change from baseline in histomorphometry of bone biopsy samples
Time frame: 0 and 24 months
Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples
Time frame: 0 and 24 months
Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius
Time frame: 0,12 and 24 months
Number of vertebral fractures (spine X-ray)
Time frame: 24 months
Change from baseline in serum procollagen type I N-terminal propeptide (PINP)
Time frame: 0,3,6,12 and 24 months
Change from baseline in serum type I collagen C-telopeptides (CTX)
Time frame: 0,3,6,12 and 24 months
Change from baseline in serum osteocalcin
Time frame: 0,3,6,12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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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.
Matti Välimäki, MD,PhD principal investigator
Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teriparatide in people with Osteoporosis, run by Helsinki University Central Hospital at 1 site in Finland.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in lumbar bone mineral density (BMD) (time frame: 0, 12 and 24 months). 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 29 Sep 2015.