DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Bone Mass; Low Bone Mineral Density; Osteoporosis; Postmenopausal Osteoporosis

Intervention: Previous denosumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis. Patients who have received denosumab and completed study 20050179 (NCT00293813), completed study 20050141 (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791) but did not enroll in study 20060289 (NCT00523341) will be included in this study. Patients who will participate in the off-treatment imaging study for 20080747 (NCT00890981) are also eligible.

Clinical Details

Official title: A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Number of Participants With Normal/Abnormal Bone Histology

Secondary outcome:

Bone Histomorphometry: Cancellous Bone Volume

Bone Histomorphometry: Trabecular Number

Bone Histomorphometry: Trabecular Separation

Bone Histomorphometry: Trabecular Thickness

Bone Histomorphometry: Cortical Width

Bone Histomorphometry: Surface Density

Bone Histomorphometry: Osteoblast - Osteoid Interface

Bone Histomorphometry: Osteoid Surface

Bone Histomorphometry: Osteoid Width

Bone Histomorphometry: Wall Thickness

Bone Histomorphometry: Eroded Surface/Bone Surface

Bone Histomorphometry: Osteoclast Number - Length Based

Bone Histomorphometry: Osteoclast Number - Surface Based

Bone Histomorphometry: Single-label Surface

Bone Histomorphometry: Double-label Surface

Bone Histomorphometry: Total Mineralizing Surface

Bone Histomorphometry: Mineral Apposition Rate

Bone Histomorphometry: Adjusted Mineral Apposition Rate

Bone Histomorphometry: Bone Formation Rate - Surface Based

Bone Histomorphometry: Bone Formation Rate - Volume Based

Bone Histomorphometry: Formation Period

Bone Histomorphometry: Activation Frequency

Bone Histomorphometry: Osteoid Volume

Bone Histomorphometry: Mineralization Lag Time

C-Telopeptide (CTX-1)

Procollagen Type 1 N-terminal Peptide (P1NP)

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Ambulatory postmenopausal women

- Received denosumab and completed study 20050179 (NCT00293813), completed study

20050141 (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791) but did not enroll in study 20060289 (NCT00523341). Patients who will participate in the off-treatment imaging study for 20080747 (NCT00890981) also are eligible.

- Completed participation in eligible studies ≥ 12 and ≤ 36 months prior to screening

- Provide signed informed consent

Exclusion Criteria:

- Did not receive denosumab in studies 20050141, 20060237, 20030216, or 20050179.

- Discontinued investigational product before end of study visit for studies 20050141,

20060237, 20030216, or 20050179.

- Received > 1 month osteoporosis treatment since having completed studies 20050141,

20060237, 20030216, or 20050179.

- Received zoledronic acid at any time after ending study participation in parent

studies 20050141, 20050179, 20030216, or 20060237.

- Newly diagnosed with any of the following conditions during the intervening period

since completing studies 20050141, 20060237, 20030216, or 20050179:

- Hyperthyroidism (stable on anti-thyroid therapy or post-ablation is allowed, if the

Thyroid Stimulating Hormone is within the normal range)

- Hypothyroidism (stable on thyroid replacement therapy is allowed, if the Thyroid

Stimulating Hormone is within the normal range)

- Hyper- or hypoparathyroidism

- Osteomalacia

- Paget's disease of bone

- Other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis

imperfecta)

- Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell

carcinoma).

- Self-reported alcohol or drug abuse within the previous 12 months.

- Permanently non-ambulatory subjects (use of assistive device eg cane, walker is

permitted).

- Has known or suspected sensitivity or contraindication to tetracycline derivatives.

- Received any investigational product other than denosumab.

- Current use of the following osteoporosis agents: bisphosphonates, calcitonin,

fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.

- Has undergone bilateral transiliac crest bone biopsy in the past.

- Current use of medications that, in the opinion of the investigator, cannot be

discontinued and may compromise the safety of the subject when undergoing the bone biopsy procedure (eg, aspirin, warfarin, high-dose heparin).

- Current use of systemic glucocorticoid therapy (topical or nasal steroids are

permitted).

- Evidence of coagulopathy that in the opinion of the investigator, may compromise

patient safety when subjected to the bone biopsy procedure.

- Any disorder that, in the opinion of the investigator, may compromise the ability of

the participant to give written informed consent and/or comply with study procedures.

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: June 2009
Last updated: October 23, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017