A Study for the Transdermal Application of Teriparatide
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Subcutaneous Teriparatide; Transdermal Teriparatide
Intervention description: Administered subcutaneously once daily for 12 months; Administered transdermally, applied once daily for 6 hours over 12 months
Intervention MeSH terms: Teriparatide; Hormones; Parathyroid Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 233.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Age Related Osteoporosis; Senile Osteoporosis

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.
    

Eligibility 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.