OsteopeniaPhase 2NCT00624481
Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD
A Phase 2 study testing Teriparatide and Teriparatide Nasal Spray in people with Osteopenia and Osteoporosis, run by Nastech Pharmaceutical Company, Inc..
Trial summary
This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density. Read more about this study
- Who is it for?
- Ages Up to 89 years, women only
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- Teriparatide and Teriparatide Nasal Spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Apr 2009
- 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 Up to 89 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal Female patients up to 89 years, inclusive;
- BMI ≤ 35 kg/m2, inclusive;
- In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
- Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
- Have a minimum of two evaluable non-fractured lumbar vertebrae.
- Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA scan at either the lumbar spine (L1-L4) or total hip
Who cannot join
- Serious Medical Condition
- History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
- Have a history of cancer within the past 5 years, except for basal cell carcinoma
- Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
- Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product.
About this study
Official title: A Phase 2, 24-Week, Multicenter, Randomized, Parallel-Group, Dose-Ranging Study To Evaluate The Effect Of Teriparatide Nasal Spray On Bone Mineral Density In Postmenopausal Women With Low Bone Mineral Density
This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.
- Conditions
- Osteopenia, Osteoporosis
- Being tested
- Teriparatide, Teriparatide Nasal Spray
- Keywords
- osteoporosis, osteopenia, bone mineral density, teriparatide
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
20ug subcutaneous injection daily for 24 weeks
Teriparatide Nasal SprayDrug
teriparatide intranasally daily for 24 weeks
Teriparatide Nasal SprayDrug
teriparatide intranasally daily for 24 weeks
Teriparatide Nasal SprayDrug
teriparatide intranasally daily for 24 weeks
Teriparatide Nasal SprayDrug
teriparatide intranasally daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Teriparatide |
| 2 | Experimental | Not described Receives: Drug: Teriparatide Nasal Spray |
| 3 | Experimental | Not described Receives: Drug: Teriparatide Nasal Spray |
| 4 | Experimental | Not described Receives: Drug: Teriparatide Nasal Spray |
| 5 | Experimental | Not described Receives: Drug: Teriparatide Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment.
Measured: 24 weeks
Secondary outcomes (3)
Change in bone mineral density from baseline to 12 weeks post treatment
Measured: 12 weeks
Safety, including hypercalcemia and nasal effects
Measured: 24 weeks
Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment
Measured: 4, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nastech Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gordon Brandt, MD, Study director, Nastech Pharmaceutical Company, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624481
- Sponsor's protocol ID
- C07-008
- Status last verified
- Mar 2008
- First submitted
- 19 Feb 2008
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, 24-Week, Multicenter, Randomized, Parallel-Group, Dose-Ranging Study To Evaluate The Effect Of Teriparatide Nasal Spray On Bone Mineral Density In Postmenopausal Women With Low Bone Mineral Density
- ClinicalTrials.gov ID
- NCT00624481
- Acronym / sponsor ID
- C07-008
- Conditions
- Osteopenia, Osteoporosis
- Keywords
- osteoporosis, osteopenia, bone mineral density, teriparatide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Nastech Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 27 Feb 2008 (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.
This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Teriparatide |
| 2 | Experimental | Drug: Teriparatide Nasal Spray |
| 3 | Experimental | Drug: Teriparatide Nasal Spray |
| 4 | Experimental | Drug: Teriparatide Nasal Spray |
| 5 | Experimental | Drug: Teriparatide Nasal Spray |
Who may qualify
- Ages
- Up to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal Female patients up to 89 years, inclusive;
- BMI ≤ 35 kg/m2, inclusive;
- In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
- Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
- Have a minimum of two evaluable non-fractured lumbar vertebrae.
Key exclusion criteria (5 listed)
- Serious Medical Condition
- History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
- Have a history of cancer within the past 5 years, except for basal cell carcinoma
- Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
- Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product.
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 |
|---|---|---|
| TeriparatideAlso: Forteo20ug subcutaneous injection daily for 24 weeks | Drug | 1 |
| Teriparatide Nasal Sprayteriparatide intranasally daily for 24 weeks | Drug | 2 |
| Teriparatide Nasal Sprayteriparatide intranasally daily for 24 weeks | Drug | 3 |
| Teriparatide Nasal Sprayteriparatide intranasally daily for 24 weeks | Drug | 4 |
| Teriparatide Nasal Sprayteriparatide intranasally daily for 24 weeks | Drug | 5 |
Primary outcome
Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment.
Time frame: 24 weeks
3 secondary outcomes
Change in bone mineral density from baseline to 12 weeks post treatment
Time frame: 12 weeks
Safety, including hypercalcemia and nasal effects
Time frame: 24 weeks
Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment
Time frame: 4, 12 and 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2008.
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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.
Gordon Brandt, MD study director
Nastech Pharmaceutical Company, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teriparatide and Teriparatide Nasal Spray in people with Osteopenia and Osteoporosis, run by Nastech Pharmaceutical Company, Inc..
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 13 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
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 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 withdrawn before enrolling participants, so there are no results.
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 in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment. (time frame: 24 weeks). 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 13 Mar 2008.