OsteoporosisPhase 2NCT01011556

A Study for the Transdermal Application of Teriparatide

A Phase 2 study testing Subcutaneous Teriparatide and Transdermal Teriparatide in people with Osteoporosis, run by Eli Lilly and Company at 18 sites in 5 countries.

Completed

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

Official record

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Trial summary

The primary purpose of this study is to help answer the following research questions: 1. How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or… Read more about this study

Who is it for?: Ages 55 to 80 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: Subcutaneous Teriparatide and Transdermal Teriparatide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 233 participants
Where: 18 sitesin 5 countries
Study dates: Nov 2009to Sep 2011
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 55 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Ambulatory, postmenopausal women.
Centrally confirmed lumbar spine or femoral neck bone mineral density (BMD) T-score of less than or equal to -2.5.
Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study.
Able to use the pen-type injection delivery system and the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver.
Able to be reached by telephone for follow-up contact between visits

Who cannot join

Abnormal laboratory values for albumin and alkaline phosphatase.
Laboratory values outside the ranges defined in the protocol for the following: Serum calcium, intact parathyroid hormone (iPTH), 25 hydroxyvitamin D, and 24-hour urine calcium
History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption.
History of malignant neoplasms in the 5 years prior to randomization, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized.
Use of a pacemaker.
Known chronic dermatological disorder, such as contact dermatitis

Show all 22Show fewer

History of allergy or sensitivity to tapes or adhesives
Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia.
Patients who have an increased baseline risk of osteosarcoma, Paget's disease of the bone, or unexplained elevations of alkaline phosphatase; or prior external beam, implant radiation therapy involving the skeleton, or previous primary skeletal malignancy.
Major fracture within the past year in the femur, tibia, humerus, or radius (with or without ulna).
Treatment with:
calcitonins in the 2 months prior to randomization.
oral, transdermal/patch, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists, selective estrogen receptor modulators, or tibolone in the 3 months prior to randomization; treatment with intravaginal estrogens in doses higher than 0.3 mg of conjugated equine estrogen, or the equivalent, for more than 3 doses per week in the 3 months prior to randomization.
androgens or other anabolic steroids in the 6 months prior to randomization.
fluorides in the 2 years prior to randomization. (Previous or current use of fluoridated water or topical dental fluoride treatments are permitted.)
oral bisphosphonates for more than 2 consecutive months in the 6 months prior to randomization; treatment with intravenous bisphosphonates in the 6 months prior to randomization; treatment with more than 1 cycle of intermittent oral bisphosphonates in the 6 months prior to randomization; or having received the last cycle of this intermittent oral regimen less than 4 weeks prior to screening.
patients receiving intravenous zoledronic acid during the 12 months prior to randomization.
vitamin D greater than 50,000 International Units (IU) per week or with any dose of calcitriol or vitamin D analogs or agonists in the 6 months prior to randomization.
systemic corticosteroids in the 1 month prior to randomization or for more than 30 days in the 1 year prior to randomization. (Ophthalmic, otic, topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.)
any other drug known to significantly affect bone metabolism in the 6 months prior to randomization.
warfarin or other coumadin anticoagulants in the 1 month prior to randomization.
any investigational drug in the 1 month prior to entry into the study.

Trial locations and contacts

18 sites in 5 countries.

Country

City, postcode or hospital

18 sites in 5 countries

Hungary7 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Balatonfüred, 8230
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Budapest, 1036
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Debrecen, 4043
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Esztergom, 2500
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Győr, 9023
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Szombathely, H-9700
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tatabánya, 2800

Other trials in Hungary

Romania4 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bucharest, 011025
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cluj-Napoca, 400006
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lasi, 700111
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Timișoara, 300736

Other trials in Romania

Estonia3 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pärnu, 80010
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tallinn, 10138
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tartu, 50410

Other trials in Estonia

Mexico3 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guadalajara, 44158
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City, 03300
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Monterrey, 64460

Other trials in Mexico

Argentina1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buenos Aires, C1128AAF

Other trials in Argentina

About this study

Official title: A Phase 2 Study for Transdermal Application of Teriparatide

The primary purpose of this study is to help answer the following research questions:

How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are).
The safety of the teriparatide skin patch and any side effects that might be associated with it.

Read the detailed description

Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transdermal dose or doses that will be comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety standpoint for use in future Phase 3 studies.

Conditions: Osteoporosis
Being tested: Subcutaneous Teriparatide, Transdermal Teriparatide
Keywords: Age Related Osteoporosis, Senile Osteoporosis
Medical subject headings: Osteoporosis

What participants receive

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

Subcutaneous TeriparatideDrug
Also called recombinant human parathyroid hormone (rhPTH) (1-34), recombinant human teriparatide, Forteo, Forsteo
Administered subcutaneously once daily for 12 months
Transdermal TeriparatideDrug
Also called synthetic human parathyroid hormone (shPTH) (1-34), synthetic human teriparatide
Administered transdermally, applied once daily for 6 hours over 12 months

Study groups in NCT01011556
Study group	Role	What they receive
20 mcg Subcutaneous Teriparatide	Active comparator	Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner. Receives: Drug: Subcutaneous Teriparatide
30 mcg Transdermal Teriparatide	Experimental	Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. Receives: Drug: Transdermal Teriparatide
50 mcg Transdermal Teriparatide	Experimental	Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. Receives: Drug: Transdermal Teriparatide
80 mcg Transdermal Teriparatide	Experimental	Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. Receives: Drug: Transdermal Teriparatide

What is being measured

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

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.
Measured: Baseline, 12 Months

Secondary outcomes (15)

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.
Measured: Baseline, 6 Months
Time Course Change of BMD Response at the Lumbar Spine
To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).
Measured: Baseline to 6 Months and 12 Months
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Measured: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
C-terminal telopeptide is a marker of bone resorption.
Measured: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Measured: Baseline, 1 Month
Convenience/Ease of Use Questionnaire (CEUQ)
CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.
Measured: baseline up to 12 months
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + [(40 - albumin) x 0.02]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).
Measured: Baseline, 12 Months
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
Measured: Baseline, 6 Months, 12 Months
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.
Measured: Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
Measured: Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).
Measured: Baseline and 1, 3, 12, and 13 Months (mon)
Pharmacokinetics Parameters: Area Under the Curve (AUC)
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Measured: Baseline, 1 Month, 3 Months, and 12 Months
Pharmacokinetics Parameters: Maximal Concentration (Cmax)
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Measured: Baseline, 1 Month, 3 Months, 12 Months
DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up
Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)
Measured: 13 Month follow-up
DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)
Measured: 13 Month follow-up

Timeline

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

Nov 2009Sep 2011

First posted11 Nov 2009 (estimated)
Study startNov 2009
Primary completionSep 2011
Study completionSep 2011

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.
Other trials for OsteoporosisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01011556
Sponsor's protocol ID: 12641
Other IDs: I2Y-MC-GHFA(c)
Status last verified: Sep 2012
First submitted: 9 Nov 2009
Last updated: 23 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

See locations

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Study at a glance

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

Official title: A Phase 2 Study for Transdermal Application of Teriparatide
ClinicalTrials.gov ID: NCT01011556
Acronym / sponsor ID: 12641
Conditions: Osteoporosis
Keywords: Age Related Osteoporosis, Senile Osteoporosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: TransPharma Medical
Study start: Nov 2009
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 11 Nov 2009 (estimated)
Results: Posted 23 Oct 2012

Clinical summary

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

The primary purpose of this study is to help answer the following research questions:

How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are).
The safety of the teriparatide skin patch and any side effects that might be associated with it.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
20 mcg Subcutaneous Teriparatide	Active comparator	Drug: Subcutaneous TeriparatideReceived 20 micrograms (mcg) subcutaneously once daily in an unblinded manner.
30 mcg Transdermal Teriparatide	Experimental	Drug: Transdermal TeriparatideReceived 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
50 mcg Transdermal Teriparatide	Experimental	Drug: Transdermal TeriparatideReceived 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
80 mcg Transdermal Teriparatide	Experimental	Drug: Transdermal TeriparatideReceived 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Who may qualify

Ages: 55 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Ambulatory, postmenopausal women.
Centrally confirmed lumbar spine or femoral neck bone mineral density (BMD) T-score of less than or equal to -2.5.
Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study.
Able to use the pen-type injection delivery system and the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver.
Able to be reached by telephone for follow-up contact between visits

Key exclusion criteria (22 listed)

Abnormal laboratory values for albumin and alkaline phosphatase.
Laboratory values outside the ranges defined in the protocol for the following: Serum calcium, intact parathyroid hormone (iPTH), 25 hydroxyvitamin D, and 24-hour urine calcium
History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption.
History of malignant neoplasms in the 5 years prior to randomization, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized.
Use of a pacemaker.

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
Subcutaneous TeriparatideAlso: recombinant human parathyroid hormone (rhPTH) (1-34), recombinant human teriparatide, Forteo, ForsteoAdministered subcutaneously once daily for 12 months	Drug	20 mcg Subcutaneous Teriparatide
Transdermal TeriparatideAlso: synthetic human parathyroid hormone (shPTH) (1-34), synthetic human teriparatideAdministered transdermally, applied once daily for 6 hours over 12 months	Drug	30 mcg Transdermal Teriparatide, 50 mcg Transdermal Teriparatide, 80 mcg Transdermal Teriparatide

Primary outcome

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Time frame: Baseline, 12 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.

15 secondary outcomes

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months
Time frame: Baseline, 6 Months
Time Course Change of BMD Response at the Lumbar Spine
Time frame: Baseline to 6 Months and 12 Months
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month
Time frame: Baseline, 1 Month
Convenience/Ease of Use Questionnaire (CEUQ)
Time frame: baseline up to 12 months
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Time frame: Baseline, 12 Months
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
Time frame: Baseline, 6 Months, 12 Months
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
Time frame: Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
Time frame: Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Time frame: Baseline and 1, 3, 12, and 13 Months (mon)
Pharmacokinetics Parameters: Area Under the Curve (AUC)
Time frame: Baseline, 1 Month, 3 Months, and 12 Months
Pharmacokinetics Parameters: Maximal Concentration (Cmax)
Time frame: Baseline, 1 Month, 3 Months, 12 Months
DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up
Time frame: 13 Month follow-up
DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
Time frame: 13 Month follow-up

Results and safety

Results posted to the registry on 23 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
20 Mcg Subcutaneous Teriparatide	58	52
30 Mcg Transdermal Teriparatide	56	48
50 Mcg Transdermal Teriparatide	55	45
80 Mcg Transdermal Teriparatide	64	51

Primary outcome: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months

Time frame: Baseline, 12 Months. Least squares mean (90% Confidence Interval). Unit: percentage change in BMD

Measure	20 Mcg Subcutaneous Teriparatide n = 54	30 Mcg Transdermal Teriparatide n = 54	50 Mcg Transdermal Teriparatide n = 51	80 Mcg Transdermal Teriparatide n = 60
Value	7.80 (6.867 to 8.730)	0.63 (-0.321 to 1.578)	0.32 (-0.657 to 1.287)	1.63 (0.739 to 2.519)

20 Mcg Subcutaneous Teriparatide vs 30 Mcg Transdermal Teriparatide: Difference in Least Square Means: -7.17 (90% CI -8.489 to -5.851), p <0.001, ANCOVA
20 Mcg Subcutaneous Teriparatide vs 50 Mcg Transdermal Teriparatide: Difference in Least Square Means: -7.48 (90% CI -8.822 to -6.144), p <0.001, ANCOVA
20 Mcg Subcutaneous Teriparatide vs 80 Mcg Transdermal Teriparatide: Difference in Least Square Means: -6.17 (90% CI -7.448 to -4.891), p <0.001, ANCOVA

Population analysed: All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model.

15 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20 Mcg Subcutaneous Teriparatide	2 of 57 (3.5%)	30 of 57 (52.6%)	Not reported
30 Mcg Transdermal Teriparatide	2 of 56 (3.6%)	33 of 56 (58.9%)	Not reported
50 Mcg Transdermal Teriparatide	1 of 54 (1.9%)	30 of 54 (55.6%)	Not reported
80 Mcg Transdermal Teriparatide	5 of 64 (7.8%)	39 of 64 (60.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

18 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Subcutaneous Teriparatide and Transdermal Teriparatide in people with Osteoporosis, run by Eli Lilly and Company at 18 sites in 5 countries.

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 5 inclusion and 22 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 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Hungary, Romania, Estonia, Mexico, Argentina. 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 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 23 Oct 2012). 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 From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months (time frame: Baseline, 12 Months). 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 NCT01011556.

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 Oct 2012.