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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study for the Transdermal Application of Teriparatide

NCTNCT01011556 (opens ClinicalTrials.gov in a new tab)Other id12641Other idI2Y-MC-GHFA(c)

Overview

Status
Completed
Phase
Phase 2
Enrollment
233 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Triple masking
Countries
5 countries

Argentina, Estonia, Hungary, Mexico, Romania

Start
Nov 2009
Primary completion
Sept 2011
Completion
Sept 2011
First posted
11 Nov 2009 (estimated)
Last update posted
23 Oct 2012 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 2

    A Study for the Transdermal Application of Teriparatide

    NCT01011556

    Nov 2009 to Sept 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 porous your bones are). 2. The safety of the teriparatide skin patch and any side effects that might be associated with it.

Interventions

  • Subcutaneous TeriparatideDrug
  • Transdermal TeriparatideDrug

Arms4

  • Active comparator

    20 mcg Subcutaneous Teriparatide

    Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner.

  • Experimental

    30 mcg Transdermal Teriparatide

    Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

  • Experimental

    50 mcg Transdermal Teriparatide

    Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

  • Experimental

    80 mcg Transdermal Teriparatide

    Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months

    Time frame · Baseline, 12 Months

    Registry description

    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.

Secondary outcomes(15)
  1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months

    Time frame · Baseline, 6 Months

    Registry description

    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.

  2. Time Course Change of BMD Response at the Lumbar Spine

    Time frame · Baseline to 6 Months and 12 Months

    Registry description

    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).

  3. Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)

    Time frame · Baseline, 1 Month, 3 Months, 6 Months, 12 Months

    Registry description

    Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.

  4. Percent Change From Baseline of C-Terminal Telopeptide (CTX)

    Time frame · Baseline, 1 Month, 3 Months, 6 Months, 12 Months

    Registry description

    C-terminal telopeptide is a marker of bone resorption.

  5. Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month

    Time frame · Baseline, 1 Month

    Registry description

    Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.

  6. Convenience/Ease of Use Questionnaire (CEUQ)

    Time frame · baseline up to 12 months

    Registry description

    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.

  7. Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours

    Time frame · Baseline, 12 Months

    Registry description

    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).

  8. Change From Baseline in Urine Calcium Excretion at 6 and 12 Months

    Time frame · Baseline, 6 Months, 12 Months

  9. 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

    Registry description

    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.

  10. 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

  11. Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels

    Time frame · Baseline and 1, 3, 12, and 13 Months (mon)

    Registry description

    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).

  12. Pharmacokinetics Parameters: Area Under the Curve (AUC)

    Time frame · Baseline, 1 Month, 3 Months, and 12 Months

    Registry description

    Due to high intra-subject variability, data was not analyzed for this outcome measure.

  13. Pharmacokinetics Parameters: Maximal Concentration (Cmax)

    Time frame · Baseline, 1 Month, 3 Months, 12 Months

    Registry description

    Due to high intra-subject variability, data was not analyzed for this outcome measure.

  14. DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up

    Time frame · 13 Month follow-up

    Registry description

    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)

  15. DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up

    Time frame · 13 Month follow-up

    Registry description

    Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, 12 Months

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

GroupValue (percentage change in BMD)
20 Mcg Subcutaneous Teriparatide7.80
30 Mcg Transdermal Teriparatide0.63
50 Mcg Transdermal Teriparatide0.32
80 Mcg Transdermal Teriparatide1.63
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, 6 Months

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months

GroupValue (percentage change in BMD)
20 Mcg Subcutaneous Teriparatide4.74
30 Mcg Transdermal Teriparatide0.16
50 Mcg Transdermal Teriparatide0.88
80 Mcg Transdermal Teriparatide1.19
Secondary outcomeLeast squares mean· Baseline to 6 Months and 12 Months

Time Course Change of BMD Response at the Lumbar Spine

GroupValue (percentage change in BMD)
20 Mcg Subcutaneous Teriparatide4.72
30 Mcg Transdermal Teriparatide0.19
50 Mcg Transdermal Teriparatide0.78
80 Mcg Transdermal Teriparatide1.19
Secondary outcomeMean· Baseline, 1 Month, 3 Months, 6 Months, 12 Months

Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)

GroupValue (percentage change in P1NP)Spread
20 Mcg Subcutaneous Teriparatide112.4765.390
30 Mcg Transdermal Teriparatide19.2935.274
50 Mcg Transdermal Teriparatide27.7831.064
80 Mcg Transdermal Teriparatide42.0653.000
Secondary outcomeMean· Baseline, 1 Month, 3 Months, 6 Months, 12 Months

Percent Change From Baseline of C-Terminal Telopeptide (CTX)

GroupValue (percentage change in CTX)Spread
20 Mcg Subcutaneous Teriparatide20.5764.980
30 Mcg Transdermal Teriparatide8.0526.070
50 Mcg Transdermal Teriparatide13.3529.384
80 Mcg Transdermal Teriparatide21.6646.572
Secondary outcomeMedian· Baseline, 1 Month

Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month

GroupValue (percentage change in P1CP)Spread
20 Mcg Subcutaneous Teriparatide80.1085.421
30 Mcg Transdermal Teriparatide4.6329.694
50 Mcg Transdermal Teriparatide12.3030.153
80 Mcg Transdermal Teriparatide23.8444.813
Secondary outcomeNumber· baseline up to 12 months

Convenience/Ease of Use Questionnaire (CEUQ)

GroupValue (participants)
20 Mcg Subcutaneous Teriparatide0
30 Mcg Transdermal Teriparatide0
50 Mcg Transdermal Teriparatide0
80 Mcg Transdermal Teriparatide0
Secondary outcomeMean· Baseline, 12 Months

Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours

GroupValue (millimole/Liter (mmol/L))Spread
20 Mcg Subcutaneous Teriparatide2.3910.0776
30 Mcg Transdermal Teriparatide2.3620.0933
50 Mcg Transdermal Teriparatide2.3890.0921
80 Mcg Transdermal Teriparatide2.3920.0915

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
20 Mcg Subcutaneous TeriparatideReceived 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.–2 / 5730 / 57
30 Mcg Transdermal TeriparatideReceived 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.–2 / 5633 / 56
50 Mcg Transdermal TeriparatideReceived 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.–1 / 5430 / 54
80 Mcg Transdermal TeriparatideReceived 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.–5 / 6439 / 64

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 55 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

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