Last updated: 11/04/2018 05:20:28

Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health

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GSK study ID
AVD111179
See study documents
Clinicaltrials.gov ID
NCT00679939
See results summary
EudraCT ID
2008-002301-38
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A 52 Week Randomized, Double-Blind, Multicenter, Mechanistic Study with a 24 Week Open-Label Follow-Up to Evaluate the Effect of AVANDIA TM on Bone in Postmenopausal Women with Type 2 Diabetes Mellitus
Trial description: The purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Adjusted percent change from baseline in femoral neck (FN) bone mineral density (BMD) via dual-energy x-ray absorptiometry (DXA) at Week 52

Timeframe: Baseline and Week 52

Adjusted percent change from baseline in femoral neck (FN) bone mineral density (BMD) via dual-energy x-ray absorptiometry (DXA) at Week 76+10 days

Timeframe: Baseline and Week 76+10 days

Adjusted percent change in femoral neck (FN) bone mineral density (BMD) via dual-energy x-ray absorptiometry (DXA) from Week 52 +10 days to Week 76+10 days

Timeframe: Week 52+10 days and Week 76+10 days

Secondary outcomes:

Adjusted percent change from baseline in femoral neck, total hip, trochanter, and lumbar spine BMD via DXA at Week 52

Timeframe: Baseline and Week 52

Adjusted percent change in femoral neck, total hip, trochanter, and lumbar spine BMD via DXA from Week 52+10 days to Week 76 + 10 days

Timeframe: Week 52 + 10 days and Week 76 + 10 days

Adjusted percent change in femoral neck, total hip, trochanter, and lumbar spine BMD via DXA from Week 52+30 days to Week 76 + 30 days

Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted percent change from baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76

Timeframe: Baseline, Week 52, and Week 76

Adjusted percent change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) from Week 52 to Week 76

Timeframe: Week 52 and Week 76

Adjusted percent change from baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76

Timeframe: Baseline, Week 52, and Week 76

Adjusted percent change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) from Week 52 to Week 76

Timeframe: Week 52 and Week 76

Adjusted percent change from baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76

Timeframe: Baseline, Week 52, and Week 76

Adjusted percent change in 25-Hydroxyvitamin D (Vitamin D) from Week 52 to Week 76

Timeframe: Week 52 and Week 76

Adjusted percent change from baseline in intact parathyroid hormone (PTH) at Week 52 and Week 76

Timeframe: Baseline, Week 52, and Week 76

Adjusted percent change in intact parathyroid hormone (PTH) from Week 52 to Week 76

Timeframe: Week 52 and Week 76

Percent change from baseline in serum estradiol at Week 52 and Week 76

Timeframe: Baseline, Week 52, and Week 76

Percent change in serum estradiol from Week 52 to Week 76

Timeframe: Week 52 and Week 76

Percent change from baseline in total testosterone at Week 52 and Week 76

Timeframe: Baseline, Week 52, and Week 76

Percent change in total testosterone from Week 52 to Week 76

Timeframe: Week 52 and Week 76

Percent change from baseline in free testosterone at Week 52 and Week 76

Timeframe: Baseline, Week 52, and Week 76

Percent change in free testosterone from Week 52 to Week 76

Timeframe: Week 52 and Week 76

Percent change from baseline in sex hormone binding globulin (SHBG) at Week 52 and Week 76

Timeframe: Baseline, Week 52, and Week 76

Percent change in sex hormone binding globulin (SHBG) from Week 52 to Week 76

Timeframe: Week 52 and Week 76

Interventions:
  • Drug: Rosiglitazone
  • Drug: Metformin
    • Enrollment:
    226
    Primary completion date:
    2010-16-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Fitzpatrick L, BilezikianJ, Wooddell M, Paul G, Kolatkar N, Nino A, Miller C, Bogado C, Arnaud C, Cobitz A. AVD111179 Mechanism of Action Study to Evaluate the Effect of Rosiglitazone on Bone in Postmenopausal Women with Type 2 Diabetes Mellitus: Study Design and Baseline Characteristics. J Drug Asses. 2011;1(.):11-19.
    Bilezikian J; Lewiecki M; Miller C; Lang T; Kravitz B; Nino A; Northcutt A; Fitzpatrick L; Brannan T; Paul G. Rosiglitazone Decreases Bone Mineral Density and Increases Bone Turnover in Postmenopausal Women with Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2013;8(4):1519-28.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    April 2008 to September 2010
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    55 - 80 years
    Accepts healthy volunteers
    No
    • Female, >55 to <80 years
    • >5 years menopausal
    • Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
    • Renal or hepatic disease (clinically significant)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Female, >55 to <80 years
    • >5 years menopausal
    • Type 2 Diabetes Mellitus (T2DM) diagnosis according to American Diabetes Association (ADA), American Association of Clinical Endocrinologists (AACE), Canadian Diabetes Association (CDA), World Health Organization/International Diabetes Federation (WHO/IDF)
    • Drug-naïve (HbA1c < or = 9.0%); OR Prior monotherapy, submaximal doses of metformin (< or = 1000mg Metformin), sulfonylureas (< or = 5mg Glyburide, < or = 10mg Glipizide or < or = 8mg glimepiride) or full dose Januvia (100mg) (HbA1c < or = 8.5%); OR Prior monotherapy, > submaximal doses of metformin (>1000mg) or sulfonylureas (>5mg Glyburide, >10mg Glipizide or >8mg glimepiride) (HbA1c < or = 7.0%)
    • Weighs <300 lbs (136.4 kg)
    • Two or more vertebra (L1-L4) suitable for BMD measurement by dual x-ray absorptiometry (DXA)
    • Absolute BMD value consistent with T-score >-2.5 at femoral neck, lumbar spine and total hip
    Exclusion criteria:
    • Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
    • Renal or hepatic disease (clinically significant)
    • Hepatocellular reaction, severe edema, or medically serious fluid event associated with thiazolidinedione (TZD)
    • Recent (<6mos) history or clinical intervention for angina or myocardial infarction or is taking nitrates
    • Any stage of heart failure, i.e. New York Heart Association (NYHA) class I-IV
    • Systolic BP >160mmHg or diastolic BP >90mmHg while on antihypertensive
    • Hypersensitivity to TZDs, biguanides
    • Prior treatment with two or more oral anti-diabetic (OAD) agents
    • Bilateral hip replacements
    • Concurrent diseases affecting bone metabolism
    • Active malabsorption syndrome
    • Serum calcium outside the central lab reference range
    • Thyroid replacement therapy, serum thyroid stimulating hormone (TSH) must be within range
    • Vitamin D deficiency
    • Previous treatment with: strontium, intravenous (IV) bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
    • Chronic systemic corticosteroid [e.g. glucocorticoid, mineralocorticoid] treatment of no more than two intra-articular injections within the past year or use of oral parenteral, or long-term, high-dose inhaled corticosteroids

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Marikina City, Philippines, 1810
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Granada, Spain, 18014
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sacramento, California, United States, 95823
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kingston, New York, United States, 12401
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Petrer, Spain, 03610
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 41 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2010-16-09
    Actual study completion date
    2010-16-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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