Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Teriparatide 40-mcg subcutaneous injection; Drug: Denosumab Injection; Drug: Alendronate Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT01750086

2012P001956

Details and patient eligibility

About

The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.

Enrollment: 27 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Must satisfy A and B and C below:

A. Women aged 45+

B. Postmenopausal

C. Osteoporotic with high risk of fracture

Exclusion criteria

• History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system
• Current alcohol or substance abuse
• Major psychiatric disorders
• Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia
• Known congenital or acquired bone disease other than osteoporosis
• Current use or past use in the past 12 months of oral bisphosphonates
• Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin
• Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months
• Any current or previous use of strontium or intravenous bisphosphonates
• Sensitivity to cell-derived drug products or teriparatide
• Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months
• Inability to sit upright for 30 minutes
• Esophageal abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

27 participants in 2 patient groups

Denosumab 60mg subcutaneous injection

Active Comparator group

Description:

Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.

Treatment:

Drug: Denosumab Injection

Drug: Teriparatide 40-mcg subcutaneous injection

Alendronate 70mg weekly x 8 weeks

Active Comparator group

Description:

Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.

Treatment:

Drug: Alendronate Oral Tablet

Drug: Teriparatide 40-mcg subcutaneous injection