OsteoporosisPhase 2NCT01604057

Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass

A Phase 2 study testing ZT-034 Low Dose Nasal Spray, ZT-034 Mid Dose Nasal Spray and ZT-034 High Dose Nasal Spray in people with Osteoporosis and Osteopenia, run by Azelon Pharmaceuticals.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass. Read more about this study

Who is it for?: Ages 45 years and older, women only
Conditions the study is for: Osteoporosis, Osteopenia
What is being tested?: ZT-034 Low Dose Nasal Spray, ZT-034 Mid Dose Nasal Spray and ZT-034 High Dose Nasal Spray
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: No sites listed yet
Study dates: Nov 2011to Jul 2012
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 45 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal Females Age ≥ 45 years.
Weight > 45 kg and < 90 kg
Normal nasal examination at baseline.
Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck

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 Parallel Group Study to Evaluate the Effect of Six Weeks of Treatment With Nasal Spray (NS) ZT-034, Compared to Subcutaneous (SC) Forteo and Placebo, on Bone Formation, as Assessed by Stimulation of Serum P1NP Levels in Postmenopausal Women With Low Bone Mass

This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.

Conditions: Osteoporosis, Osteopenia
Being tested: ZT-034 Low Dose Nasal Spray, ZT-034 Mid Dose Nasal Spray, ZT-034 High Dose Nasal Spray, Teriparatide, Placebo
Medical subject headings: Osteoporosis, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZT-034 Low Dose Nasal SprayDrug
Nasal Spray
ZT-034 Mid Dose Nasal SprayDrug
Nasal Spray
ZT-034 High Dose Nasal SprayDrug
Nasal Spray
TeriparatideDrug
Also called Forteo
20 mcg subcutaneous daily
PlaceboDrug
Nasal Spray

Study groups in NCT01604057
Study group	Role	What they receive
Low Dose Nasal Spray	Experimental	Not described Receives: Drug: ZT-034 Low Dose Nasal Spray
Mid Dose Nasal Spray	Experimental	Not described Receives: Drug: ZT-034 Mid Dose Nasal Spray
High Dose Nasal Spray	Experimental	Not described Receives: Drug: ZT-034 High Dose Nasal Spray
Forteo	Active comparator	20ug subcutaneous injection daily Receives: Drug: Teriparatide
Placebo Nasal Spray	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Serum P1NP from baseline to end of treatment.
Measured: 6 weeks

Secondary outcomes (1)

Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)
Measured: baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Jul 2012

First posted23 May 2012 (estimated)
Study startNov 2011
Primary completionJul 2012 (estimated)
Study completionJul 2012 (estimated)

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.
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: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01604057
Sponsor's protocol ID: ZT-3201
Status last verified: May 2012
First submitted: 18 May 2012
Last updated: 23 May 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis

All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Parallel Group Study to Evaluate the Effect of Six Weeks of Treatment With Nasal Spray (NS) ZT-034, Compared to Subcutaneous (SC) Forteo and Placebo, on Bone Formation, as Assessed by Stimulation of Serum P1NP Levels in Postmenopausal Women With Low Bone Mass
ClinicalTrials.gov ID: NCT01604057
Acronym / sponsor ID: ZT-3201
Conditions: Osteoporosis, Osteopenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 130 participants (actual)
Lead sponsor: Azelon PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Jul 2012 (estimated)
Study completion: Jul 2012 (estimated)
First posted: 23 May 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.

This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.

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
Low Dose Nasal Spray	Experimental	Drug: ZT-034 Low Dose Nasal Spray
Mid Dose Nasal Spray	Experimental	Drug: ZT-034 Mid Dose Nasal Spray
High Dose Nasal Spray	Experimental	Drug: ZT-034 High Dose Nasal Spray
Forteo	Active comparator	Drug: Teriparatide20ug subcutaneous injection daily
Placebo Nasal Spray	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 45 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Postmenopausal Females Age ≥ 45 years.
Weight > 45 kg and < 90 kg
Normal nasal examination at baseline.
Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck

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
ZT-034 Low Dose Nasal SprayNasal Spray	Drug	Low Dose Nasal Spray
ZT-034 Mid Dose Nasal SprayNasal Spray	Drug	Mid Dose Nasal Spray
ZT-034 High Dose Nasal SprayNasal Spray	Drug	High Dose Nasal Spray
TeriparatideAlso: Forteo20 mcg subcutaneous daily	Drug	Forteo
PlaceboNasal Spray	Drug	Placebo Nasal Spray

Primary outcome

Change in Serum P1NP from baseline to end of treatment.
Time frame: 6 weeks

1 secondary outcome

Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)
Time frame: baseline and 6 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis

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.

Brian MacDonald study director

Azelon Pharmaceuticals

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZT-034 Low Dose Nasal Spray, ZT-034 Mid Dose Nasal Spray and ZT-034 High Dose Nasal Spray in people with Osteoporosis and Osteopenia, run by Azelon Pharmaceuticals.

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 4 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: status not confirmed, as of the sponsor's last update on 23 May 2012. 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. 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?

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?

Change in Serum P1NP from baseline to end of treatment. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01604057.

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 23 May 2012.