A Study for the Transdermal Application of Teriparatide
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Subcutaneous Teriparatide (Drug); Transdermal Teriparatide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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, Affiliation: Eli Lilly and Company
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 porous your bones are).
2. The safety of the teriparatide skin patch and any side effects that might be associated
with it.
Clinical Details
Official title: A Phase 2 Study for Transdermal Application of Teriparatide
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Secondary outcome: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 MonthsTime Course Change of BMD Response at the Lumbar Spine Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) Percent Change From Baseline of C-Terminal Telopeptide (CTX) Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month Convenience/Ease of Use Questionnaire (CEUQ) Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours Change From Baseline in Urine Calcium Excretion at 6 and 12 Months Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels Pharmacokinetics Parameters: Area Under the Curve (AUC) Pharmacokinetics Parameters: Maximal Concentration (Cmax) DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
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.
Eligibility
Minimum age: 55 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
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, Argentina
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., Parnu 80010, Estonia
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., Tallin 10138, Estonia
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, Estonia
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., Balatonfured 8230, Hungary
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, Hungary
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, Hungary
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, Hungary
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., Gyor 9023, Hungary
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, Hungary
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., Tatabanya 2800, Hungary
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, Mexico
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, Mexico
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, Mexico
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, Romania
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, Romania
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, Romania
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., Timisoara 300736, Romania
Additional Information
Starting date: November 2009
Last updated: September 21, 2012
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