Conditions: Osteoporosis
Keywords: Age Related Osteoporosis Senile Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 233
Healthy volunteers: no

Brief 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.

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.

Arms:
arm 1: Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner. arm 2: Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. arm 3: Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. arm 4: Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Interventions: intervention 1: Subcutaneous Teriparatide intervention 2: Transdermal Teriparatide
Intervention descriptions: intervention 1: Administered subcutaneously once daily for 12 months intervention 2: Administered transdermally, applied once daily for 6 hours over 12 months

Protocol document: