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Adult Trials: 18+ Years
- Individuals with acromegaly
- On pegvisomant therapy with a normal IGF-1 level for at least 1 year
- Malignancy (except cured basal, squamous cell skin carcinoma or other cured cancers
free from recurrence > 3 years)
- Pregnancy or lactation within last 12 months
- Untreated primary hyperparathyroidism, hyper- or hypothyroidism
- Cushing's syndrome
- Prolactin-secreting pituitary adenoma
- GH deficiency
- On current drug therapy for osteoporosis
- Diabetes mellitus
- Renal insufficiency
- Liver disease
- Current or past use of glucocorticoids (more than physiologic dose), anticonvulsants,
anticoagulants, methotrexate, aromatase inhibitors
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Bone MicroArchitecture in Acromegaly | ||||||
| Official Title | Cross-sectional Study of Bone Density, Bone Microarchitecture, Vertebral Fractures and Trabecular Bone Score in Patients With Acromegaly Treated With Pegvisomant Compared to Patients With Untreated Active Acromegaly | ||||||
| Brief Summary | The investigators will conduct a cross-sectional study of bone density, bone microarchitecture, vertebral fractures and trabecular bone score in 25 patients with acromegaly treated with Pegvisomant, the growth hormone (GH) receptor antagonist for at least 1 year and with normal insulin-like growth factor-1 (IGF-1) levels. This study aims to describe the bone architecture and associated biochemical indices of bone turnover and metabolism in patients with active acromegaly and how these are altered with treatment of the disease. | ||||||
| Detailed Description | Growth hormone (GH) and Insulin-Like Growth Factor-1 (IGF-1) are important regulators of bone modeling and remodeling, fundamental to maintenance of normal skeletal integrity. In acromegaly, a disease characterized by longstanding exposure to excess GH and IGF-1, these hormones induce marked skeletal changes. Most dual energy X-ray absorptiometry (DXA) studies report that bone mineral density (BMD) is normal in acromegaly. Despite this, however, there is mounting evidence that bone health is adversely affected in patients with both active and successfully treated acromegaly. | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Retention: Samples Without DNA Description: Peripheral blood specimens | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | 25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year will be studied. Patients will be on stable doses of any pituitary hormone supplements for 3 months prior to study entry including gonadal steroid replacement for men or premenopausal women. Hypogonadal men and premenopausal women will be replaced with clinically appropriate sex steroid replacement. Subjects will be 50% females. | ||||||
| Condition |
| ||||||
| Intervention | Drug: Pegvisomant
Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied. Other Name: Somavert | ||||||
| Study Groups/Cohorts | Acromegaly patients on pegvisomant
25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year. Intervention: Drug: Pegvisomant | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Unknown status | ||||||
| Estimated Enrollment | 25 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | March 2020 | ||||||
| Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender |
| ||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03225040 | ||||||
| Other Study ID Numbers | AAAE5304 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement |
| ||||||
| Responsible Party | Pamela U. Freda, Columbia University | ||||||
| Study Sponsor | Columbia University | ||||||
| Collaborators | Pfizer | ||||||
| Investigators |
| ||||||
| PRS Account | Columbia University | ||||||
| Verification Date | February 2019 | ||||||