OsteoporosisPhase 2NCT00489918

Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis

A Phase 2 study testing teriparatide in people with Osteoporosis, run by Zosano Pharma Corporation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis Read more about this study

Who is it for?: Ages 50 years and older, women only
Conditions the study is for: Osteoporosis
What is being tested?: teriparatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 165 participants
Where: No sites listed yet
Study dates: Jun 2007to Aug 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Healthy postmenopausal women age 50 years or older
At least three lumbar vertebrae (L1-L4) must be evaluable by dual energy x-ray absorptiometry (DXA) for bone mineral densitometry that is, without fracture or significant degenerative disease, as determined by the central imaging facility
Have osteoporosis defined as: Either a T-score of ≤ -2.5 at the lumbar spine, femoral neck, or total hip, AND a T-score of at least < -1.0 at the lumbar spine; or A T-score of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, AND at least one vertebral fracture;

Who cannot join

Active hepatitis;
Active pancreatitis;
Unstable cardiac disease;
Unstable pulmonary disease;
Celiac disease;
Hyper- or hypo-parathyroidism;

Show all 28Show fewer

Hyperthyroidism;
Cushing's disease;
Osteomalacia;
Paget's disease;
Osteogenesis imperfecta;
Known blood disorders;
History of kidney stones;
Impaired renal function;
Autoimmune diseases;
Bone metastases or a history of skeletal malignancies;
Cancer history that includes any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for at least 1 year from the time of original resection;
Any condition or disease that may interfere with the ability to have or the evaluation of a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or >1 lumbar vertebral fracture in L1-L4;
More than 4 vertebral fractures in T4-L4;
Bilateral hip replacements;
Use of fluoride (e.g. fluoride therapy for osteoporosis) or strontium at any time;
Have received methotrexate or immunomodulatory agents with antiproliferative activity;
With known dermatological disorders that would interfere with the study procedures or assessments, or with a history of contact dermatitis;
With known allergy or sensitivity to tapes, adhesives, PTH, teriparatide or its analogs, or components of the Macroflux® systems;
Who, in the opinion of the investigator, should not participate in the study, or may not be capable of following the study schedule for any reason; and
Unwillingness or inability to abide by the requirements of the study.
Have received any intravenous (IV) administered bisphosphonates in the past 24 months, or >2 doses of IV administered bisphosphonates total;
Use of oral bisphosphonates before randomization, including investigational bisphosphonates, unless: <6 months of treatment and off for 6 months, or 6-12 months of treatment and off for 2 years, or >12 months of treatment and off for 5 years;

About this study

Official title: A Dose Ranging Study of the Effects of Macroflux® PTH Compared With Macroflux® Placebo and FORTEO® in Postmenopausal Women With Osteoporosis

A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis

Conditions: Osteoporosis
Being tested: teriparatide
Medical subject headings: Osteoporosis

What participants receive

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

teriparatideDrug
Also called PTH(1-34)
Macroflux® patch applied to the abdomen for 30 minutes daily
teriparatideDrug
Also called FORTEO®
FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh

Study groups in NCT00489918
Study group	Role	What they receive
Macroflux® placebo	Placebo comparator	Macroflux® placebo patch Receives: Drug: teriparatide
Macroflux® 20 mcg	Experimental	Macroflux® 20 mcg patch Receives: Drug: teriparatide
Macroflux® 30 mcg	Experimental	Macroflux® 30 mcg patch Receives: Drug: teriparatide
Macroflux® 40 mcg	Experimental	Macroflux® 40 mcg patch Receives: Drug: teriparatide
FORTEO®	Active comparator	FORTEO® 20 mcg injection Receives: Drug: teriparatide

What is being measured

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

Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24
Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24
Measured: 24 weeks

Secondary outcomes (4)

Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12
Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12
Measured: 12 weeks
Absolute Change in Lumbar Spine BMD: Baseline to Week 12
Absolute Change in Lumbar Spine BMD from Baseline to Week 12
Measured: 12 weeks
Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24
Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24
Measured: 24 Weeks
Percent Change in Femoral Neck BMD: Baseline to Week 24
Percent Change in Femoral Neck BMD from Baseline to Week 24
Measured: 24 Weeks

Timeline

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

Jun 2007Aug 2008

First posted21 Jun 2007 (estimated)
Study startJun 2007
Primary completionApr 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00489918
Sponsor's protocol ID: CP-2006-001
Status last verified: Jul 2018
First submitted: 19 Jun 2007
Last updated: 31 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cosman F, Lane NE, Bolognese MA, Zanchetta JR, Garcia-Hernandez PA, Sees K, Matriano JA, Gaumer K, Daddona PE. Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. J Clin Endocrinol Metab. 2010 Jan;95(1):151-8. doi: 10.1210/jc.2009-0358. Epub 2009 Oct 26.
PubMed 19858319

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
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The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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RecruitingObservational study
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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Ranging Study of the Effects of Macroflux® PTH Compared With Macroflux® Placebo and FORTEO® in Postmenopausal Women With Osteoporosis
ClinicalTrials.gov ID: NCT00489918
Acronym / sponsor ID: CP-2006-001
Conditions: Osteoporosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Zosano Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Apr 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 21 Jun 2007 (estimated)
Results: Posted 31 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis

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
Macroflux® placebo	Placebo comparator	Drug: teriparatideMacroflux® placebo patch
Macroflux® 20 mcg	Experimental	Drug: teriparatideMacroflux® 20 mcg patch
Macroflux® 30 mcg	Experimental	Drug: teriparatideMacroflux® 30 mcg patch
Macroflux® 40 mcg	Experimental	Drug: teriparatideMacroflux® 40 mcg patch
FORTEO®	Active comparator	Drug: teriparatideFORTEO® 20 mcg injection

Who may qualify

Ages: 50 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy postmenopausal women age 50 years or older
At least three lumbar vertebrae (L1-L4) must be evaluable by dual energy x-ray absorptiometry (DXA) for bone mineral densitometry that is, without fracture or significant degenerative disease, as determined by the central imaging facility
Have osteoporosis defined as: Either a T-score of ≤ -2.5 at the lumbar spine, femoral neck, or total hip, AND a T-score of at least < -1.0 at the lumbar spine; or A T-score of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, AND at least one vertebral fracture;

Key exclusion criteria (28 listed)

Active hepatitis;
Active pancreatitis;
Unstable cardiac disease;
Unstable pulmonary disease;
Celiac disease;

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: PTH(1-34)Macroflux® patch applied to the abdomen for 30 minutes daily	Drug	Macroflux® 20 mcg, Macroflux® 30 mcg, Macroflux® 40 mcg, Macroflux® placebo
teriparatideAlso: FORTEO®FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh	Drug	FORTEO®

Primary outcome

Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24
Time frame: 24 weeks
Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24

4 secondary outcomes

Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12
Time frame: 12 weeks
Absolute Change in Lumbar Spine BMD: Baseline to Week 12
Time frame: 12 weeks
Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24
Time frame: 24 Weeks
Percent Change in Femoral Neck BMD: Baseline to Week 24
Time frame: 24 Weeks

Results and safety

Results posted to the registry on 31 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Macroflux® Placebo	33	31
Macroflux® 20 mcg	34	32
Macroflux® 30 mcg	32	28
Macroflux® 40 mcg	33	32
FORTEO®	33	32

Primary outcome: Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24

Time frame: 24 weeks. Mean (Standard Deviation). Unit: percent change

Measure	Macroflux® Placebo n = 33	Macroflux® 20 mcg n = 34	Macroflux® 30 mcg n = 32	Macroflux® 40 mcg n = 33	FORTEO® n = 33
Value	-0.33 (3.467)	2.96 (3.524)	3.47 (3.575)	4.97 (4.114)	3.55 (3.730)

Population analysed: Intent to treat (ITT)/Safety Population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Macroflux® Placebo	1 of 33 (3%)	29 of 33 (87.9%)	Not reported
Macroflux® 20 mcg	1 of 34 (2.9%)	32 of 34 (94.1%)	Not reported
Macroflux® 30 mcg	0 of 32 (0%)	31 of 32 (96.9%)	Not reported
Macroflux® 40 mcg	0 of 33 (0%)	30 of 33 (90.9%)	Not reported
FORTEO®	0 of 33 (0%)	23 of 33 (69.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19858319Cosman F, Lane NE, Bolognese MA, Zanchetta JR, Garcia-Hernandez PA, Sees K, Matriano JA, Gaumer K, Daddona PE. Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. J Clin Endocrinol Metab. 2010 Jan;95(1):151-8. doi: 10.1210/jc.2009-0358. Epub 2009 Oct 26.

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.

Thorsten von Stein, MD, Ph.D study director

Zosano Pharma Corporation

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing teriparatide in people with Osteoporosis, run by Zosano Pharma Corporation.

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 28 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 31 Jul 2018. 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?

Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 (time frame: 24 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 NCT00489918, which also lists 1 linked publication.

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 31 Jul 2018.