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:

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2011

Teriparatide 20 mcg/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.

Intervention(s) in this Clinical Trial

• Drug: Subcutaneous Teriparatide
  • Administered subcutaneously once daily for 12 months
• Drug: Transdermal Teriparatide
  • Administered transdermally, applied once daily for 6 hours over 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 20 mcg Subcutaneous Teriparatide
• Experimental: 30 mcg Transdermal Teriparatide
• Experimental: 50 mcg Transdermal Teriparatide
• Experimental: 80 mcg Transdermal Teriparatide

Primary Measures

• Percent Change from Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 months
  • Time Frame: Baseline, 12 Months
    Safety Issue?: No

Secondary Measures

• Percent Change from Baseline in Lumbar Spine BMD at 6 months
  • Time Frame: Baseline, 6 Months
    Safety Issue?: No
• Percent Change from Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) at 1 and 3 months
  • Time Frame: Baseline, 1 Month, 3 Months
    Safety Issue?: No
• Percent Change from Baseline of C-Terminal Telopeptide (CTX) at 1 and 3 months
  • Time Frame: Baseline, 1 Month, 3 Months
    Safety Issue?: No
• Change from Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 month
  • Time Frame: Baseline, 1 Month
    Safety Issue?: No
• Convenience/Ease of Use Questionnaire (CEUQ) at 12 months
  • Time Frame: 12 Months
    Safety Issue?: No
• Change in Serum Calcium with and without Adjustments for Serum Albumin from Predose to after 4 and 6 hours
  • Time Frame: Baseline, 3 Months, 6 Months, 12 Months
    Safety Issue?: Yes
• Change from Baseline in Urine Calcium Excretion at 6 and 12 months
  • Time Frame: Baseline, 6 Months, 12 Months
    Safety Issue?: Yes
• Difference in Supine to Standing Systolic and Diastolic Blood Pressure at Predose, 30 minutes prior, 30 minutes, and 2 hour Postdose
  • Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 8 Months, 12 Months
    Safety Issue?: Yes
• Difference in Supine to Standing Pulse Rate Measured at Predose, 30 minutes prior, 30 minutes, and 2 hour Postdose
  • Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 8 Months, 12 Months
    Safety Issue?: Yes
• PTH Antibody levels at 12 Months
  • Time Frame: 12 Months
    Safety Issue?: No
• Pharmacokinetics Parameters: Area Under the Curve (AUC) from Post dose 30 minutes to 4 hours
  • Time Frame: Baseline, 1 Month, 3 Months, and 12 Months
    Safety Issue?: No
• Pharmacokinetics Parameters: Maximal Concentration (Cmax) from Post Dose 30 minutes to 4 hours
  • Time Frame: Baseline, 1 Month, 3 Months, 12 Months
    Safety Issue?: No
• DRAIZE Edema Assessment at Baseline through 13 Months followup
  • Time Frame: Baseline through 13 month follow up
    Safety Issue?: Yes
• DRAIZE Erythema Assessment at Baseline through 13 Months followup
  • Time Frame: Baseline through 13 month follow up
    Safety Issue?: Yes

Inclusion Criteria:

• Ambulatory, postmenopausal women.
• Centrally confirmed lumbar spine or femoral neck BMD T-score of less than or equal to -2.5.
• Without language barrier, cooperative, expected to return for all follow-up procedures, & have given informed consent after being informed of the risks, medications, & procedures to be used in the study.
• Able to use the pen-type injection delivery system & 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, iPTH, 25 hydroxyvitamin D, & 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, &
• 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.

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 >50,000 IU/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.
• 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).

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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  

Overall Contact: There may be multiple sites in this clinical trial. (1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559) 

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01011556

Study ID Number: 12641

ClinicalTrials.gov Identifier: NCT01011556

Health Authority: Hungary: National Institute of Pharmacy