A Study for the Transdermal Application of Teriparatide

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

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.

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 Months

Time 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.

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.

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

Starting date: November 2009
Last updated: September 21, 2012