NCT00145977

Brief Summary

The purpose of this study is to determine if a new test for osteoporosis can be useful in monitoring treatment. We are studying a new method for examining the quality of bone by an experimental method of computerized analysis of radiographic images (x-ray pictures) of the heel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

September 11, 2018

Completed
Last Updated

September 11, 2018

Status Verified

August 1, 2018

Enrollment Period

8.4 years

First QC Date

September 1, 2005

Results QC Date

July 26, 2016

Last Update Submit

August 9, 2018

Conditions

OsteoporosisOsteopenia

Keywords

osteoporosisbone densitywomenendocrinemusculoskeletalmetabolic

Outcome Measures

Primary Outcomes (1)

  • Changes in Lumbar Spine BMD +/- Treatment With Alendronate

    Percent Change in lumbar spine BMD from Baseline to Month 24

    Baseline to Month 24

Secondary Outcomes (9)

  • Changes in Peripheral Heel BMD +/- Treatment With Alendronate

    Baseline to Month 24

  • Changes in Femoral Neck BMD +/- Treatment With Alendronate

    Baseline to Month 24

  • Changes in Total Hip BMD +/- Treatment With Alendronate

    Baseline to Month 24

  • Changes in Radiographic Texture Analysis (RTA) Integrated Root Mean Square (iRMS) From Baseline to Month 24

    Baseline to Month 24

  • Changes in Radiographic Texture Analysis (RTA) Feature Standard Deviation of Root Mean Square (sdRMS) From Baseline to Month 24

    Baseline to Month 24

  • +4 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.

Drug: AlendronateDietary Supplement: Calcium CitrateDietary Supplement: Vitamin D

Control

ACTIVE COMPARATOR

All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.

Dietary Supplement: Calcium CitrateDietary Supplement: Vitamin D

Interventions

AlendronateDRUG

alendronate 70 mg once weekly

Also known as: fosamax
Experimental
Calcium CitrateDIETARY_SUPPLEMENT

600 mg of calcium citrate

ControlExperimental
Vitamin DDIETARY_SUPPLEMENT

500 mg of Vitamin D consumed with the evening meal.

ControlExperimental

Eligibility Criteria

Age59 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study will enroll 40 postmenopausal women with a T score \< -2 either at the lumbar spine or the femoral neck: 20 who decide to begin anti-resorptive therapy (treated group), and 20 women who decline such therapy (control group). We will attempt to match the patients and the controls for T score (within 0.3) and age (within 5 years).
  • All study participants will be:
  • at least 3 years past the last menstrual period,
  • not on HRT, Raloxifene or calcitonin for at least 6 months.

You may not qualify if:

  • All study participants will not be on bisphosphonates during the previous 12 months.
  • Women with secondary causes of osteoporosis will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (28)

  • Genant HK, Engelke K, Fuerst T, Gluer CC, Grampp S, Harris ST, Jergas M, Lang T, Lu Y, Majumdar S, Mathur A, Takada M. Noninvasive assessment of bone mineral and structure: state of the art. J Bone Miner Res. 1996 Jun;11(6):707-30. doi: 10.1002/jbmr.5650110602. No abstract available.

    PMID: 8725168BACKGROUND

  • Melton LJ 3rd, Eddy DM, Johnston CC Jr. Screening for osteoporosis. Ann Intern Med. 1990 Apr 1;112(7):516-28. doi: 10.7326/0003-4819-112-7-516.

    PMID: 2180356BACKGROUND

  • Melton LJ 3rd, Atkinson EJ, O'Fallon WM, Wahner HW, Riggs BL. Long-term fracture prediction by bone mineral assessed at different skeletal sites. J Bone Miner Res. 1993 Oct;8(10):1227-33. doi: 10.1002/jbmr.5650081010.

    PMID: 8256660BACKGROUND

  • National Osteoporosis Foundation: Physicians guide to prevention and treatment of osteoporosis, . 1999, Exerpta Medica, Inc.: Belle Mead, New Jersey.

    BACKGROUND

  • Cummings SR, Black DM, Nevitt MC, Browner W, Cauley J, Ensrud K, Genant HK, Palermo L, Scott J, Vogt TM. Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group. Lancet. 1993 Jan 9;341(8837):72-5. doi: 10.1016/0140-6736(93)92555-8.

    PMID: 8093403BACKGROUND

  • Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. BMJ. 1996 May 18;312(7041):1254-9. doi: 10.1136/bmj.312.7041.1254.

    PMID: 8634613BACKGROUND

  • Melton LJ 3rd, Kan SH, Frye MA, Wahner HW, O'Fallon WM, Riggs BL. Epidemiology of vertebral fractures in women. Am J Epidemiol. 1989 May;129(5):1000-11. doi: 10.1093/oxfordjournals.aje.a115204.

    PMID: 2784934BACKGROUND

  • Ross PD, Wasnich RD, Davis JW. Fracture prediction models for osteoporosis prevention. Bone. 1990;11(5):327-31. doi: 10.1016/8756-3282(90)90088-g.

    PMID: 2123644BACKGROUND

  • Wasnich RD, Davis JW, Ross PD. Appropriate clinical application of bone density measurements. J Am Med Womens Assoc (1972). 1990 May-Jun;45(3):99-102.

    PMID: 2335697BACKGROUND

  • Parfitt AM. Trabecular bone architecture in the pathogenesis and prevention of fracture. Am J Med. 1987 Jan 26;82(1B):68-72. doi: 10.1016/0002-9343(87)90274-9.

    PMID: 3544835BACKGROUND

  • Link TM, Majumdar S, Grampp S, Guglielmi G, van Kuijk C, Imhof H, Glueer C, Adams JE. Imaging of trabecular bone structure in osteoporosis. Eur Radiol. 1999;9(9):1781-8. doi: 10.1007/s003300050922.

    PMID: 10602950BACKGROUND

  • Jiang C, Giger ML, Chinander MR, Martell JM, Kwak S, Favus MJ. Characterization of bone quality using computer-extracted radiographic features. Med Phys. 1999 Jun;26(6):872-9. doi: 10.1118/1.598604.

    PMID: 10436887BACKGROUND

  • Caligiuri P, Giger ML, Favus MJ, Jia H, Doi K, Dixon LB. Computerized radiographic analysis of osteoporosis: preliminary evaluation. Radiology. 1993 Feb;186(2):471-4. doi: 10.1148/radiology.186.2.8421753.

    PMID: 8421753BACKGROUND

  • Caligiuri P, Giger ML, Favus M. Multifractal radiographic analysis of osteoporosis. Med Phys. 1994 Apr;21(4):503-8. doi: 10.1118/1.597390.

    PMID: 8058015BACKGROUND

  • Chinander MR, Giger ML, Martell JM, Jiang C, Favus MJ. Computerized radiographic texture measures for characterizing bone strength: a simulated clinical setup using femoral neck specimens. Med Phys. 1999 Nov;26(11):2295-300. doi: 10.1118/1.598743.

    PMID: 10587210BACKGROUND

  • Chinander MR, Giger ML, Martell JM, Favus MJ. Computerized analysis of radiographic bone patterns: effect of imaging conditions on performance. Med Phys. 2000 Jan;27(1):75-85. doi: 10.1118/1.598858.

    PMID: 10659740BACKGROUND

  • Benhamou CL, Lespessailles E, Jacquet G, Harba R, Jennane R, Loussot T, Tourliere D, Ohley W. Fractal organization of trabecular bone images on calcaneus radiographs. J Bone Miner Res. 1994 Dec;9(12):1909-18. doi: 10.1002/jbmr.5650091210.

    PMID: 7872056BACKGROUND

  • Jiang C, Pitt RE, Bertram JE, Aneshansley DJ. Fractal-based image texture analysis of trabecular bone architecture. Med Biol Eng Comput. 1999 Jul;37(4):413-8. doi: 10.1007/BF02513322.

    PMID: 10696694BACKGROUND

  • Majumdar S, Weinstein RS, Prasad RR. Application of fractal geometry techniques to the study of trabecular bone. Med Phys. 1993 Nov-Dec;20(6):1611-9. doi: 10.1118/1.596948.

    PMID: 8309433BACKGROUND

  • Maragos, P., Fractal signal analysis using mathematicl morphology. Advances in Electronics and Electron Physics, 1994. 88: p. 199-246.

    BACKGROUND

  • Looker AC, Bauer DC, Chesnut CH 3rd, Gundberg CM, Hochberg MC, Klee G, Kleerekoper M, Watts NB, Bell NH. Clinical use of biochemical markers of bone remodeling: current status and future directions. Osteoporos Int. 2000;11(6):467-80. doi: 10.1007/s001980070088.

    PMID: 10982161BACKGROUND

  • Bauer DC, Sklarin PM, Stone KL, Black DM, Nevitt MC, Ensrud KE, Arnaud CD, Genant HK, Garnero P, Delmas PD, Lawaetz H, Cummings SR. Biochemical markers of bone turnover and prediction of hip bone loss in older women: the study of osteoporotic fractures. J Bone Miner Res. 1999 Aug;14(8):1404-10. doi: 10.1359/jbmr.1999.14.8.1404.

    PMID: 10457273BACKGROUND

  • Garnero P, Hausherr E, Chapuy MC, Marcelli C, Grandjean H, Muller C, Cormier C, Breart G, Meunier PJ, Delmas PD. Markers of bone resorption predict hip fracture in elderly women: the EPIDOS Prospective Study. J Bone Miner Res. 1996 Oct;11(10):1531-8. doi: 10.1002/jbmr.5650111021.

    PMID: 8889854BACKGROUND

  • van Daele PL, Seibel MJ, Burger H, Hofman A, Grobbee DE, van Leeuwen JP, Birkenhager JC, Pols HA. Case-control analysis of bone resorption markers, disability, and hip fracture risk: the Rotterdam study. BMJ. 1996 Feb 24;312(7029):482-3. doi: 10.1136/bmj.312.7029.482. No abstract available.

    PMID: 8597681BACKGROUND

  • Ravn P, Clemmesen B, Christiansen C. Biochemical markers can predict the response in bone mass during alendronate treatment in early postmenopausal women. Alendronate Osteoporosis Prevention Study Group. Bone. 1999 Mar;24(3):237-44. doi: 10.1016/s8756-3282(98)00183-5.

    PMID: 10071916BACKGROUND

  • Greenspan SL, Parker RA, Ferguson L, Rosen HN, Maitland-Ramsey L, Karpf DB. Early changes in biochemical markers of bone turnover predict the long-term response to alendronate therapy in representative elderly women: a randomized clinical trial. J Bone Miner Res. 1998 Sep;13(9):1431-8. doi: 10.1359/jbmr.1998.13.9.1431.

    PMID: 9738515BACKGROUND

  • Chesnut CH 3rd, Bell NH, Clark GS, Drinkwater BL, English SC, Johnson CC Jr, Notelovitz M, Rosen C, Cain DF, Flessland KA, Mallinak NJ. Hormone replacement therapy in postmenopausal women: urinary N-telopeptide of type I collagen monitors therapeutic effect and predicts response of bone mineral density. Am J Med. 1997 Jan;102(1):29-37. doi: 10.1016/s0002-9343(96)00387-7.

    PMID: 9209198BACKGROUND

  • Bjarnason NH, Bjarnason K, Hassager C, Christiansen C. The response in spinal bone mass to tibolone treatment is related to bone turnover in elderly women. Bone. 1997 Feb;20(2):151-5. doi: 10.1016/s8756-3282(96)00335-3.

    PMID: 9028540BACKGROUND

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Interventions

AlendronateCalcium CitrateVitamin D

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCalcium CompoundsInorganic ChemicalsCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Tamara Vokes, MD
Organization
The University of Chicago
tvokes@medicine.bsd.uchicago.edu
773-702-1465

Study Officials

  • Tamara Vokes, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

July 1, 2001

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 11, 2018

Results First Posted

September 11, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)