Low-fat, increased fruit, vegetable, and grain dietary pattern, fractures, and bone mineral density: the Women's Health Initiative Dietary Modification Trial

Anne McTiernan, Jean Wactawski-Wende, LieLing Wu, Rebecca J Rodabough, Nelson B Watts, Frances Tylavsky, Ruth Freeman, Susan Hendrix, Rebecca Jackson, Women's Health Initiative Investigators, Barbara Alving, Jacques Rossouw, Linda Pottern, Shari Ludlam, Joan McGowan, Nancy Geller, Leslie Ford, Ross Prentice, Garnet Anderson, Andrea LaCroix, Ruth Patterson, Anne McTiernan, Barbara Cochrane, Julie Hunt, Lesley Tinker, Charles Kooperberg, Martin McIntosh, C Y Wang, Chu Chen, Deborah Bowen, Alan Kristal, Janet Stanford, Nicole Urban, Noel Weiss, Emily White, Sally Shumaker, Ronald Prineas, Michelle Naughton, Evan Stein, Peter Laskarzewski, Steven R Cummings, Michael Nevitt, Lisa Palermo, Lisa Harnack, Frank Cammarata, Steve Lindenfelser, Bruce Psaty, Susan Heckbert, Sylvia Wassertheil-Smoller, William Frishman, Judith Wylie-Rosett, David Barad, Ruth Freeman, Jennifer Hays, Ronald Young, Jill Anderson, Sandy Lithgow, Paul Bray, JoAnn Manson, J Michael Gaziano, Claudia Chae, Kathryn Rexrode, Caren Solomon, Annlouise R Assaf, Carol Wheeler, Charles Eaton, Michelle Cyr, Lawrence Phillips, Margaret Pedersen, Ora Strickland, Margaret Huber, Vivian Porter, Shirley A A Beresford, Vicky M Taylor, Nancy F Woods, Maureen Henderson, Robyn Andersen, Judith Hsia, Nancy Gaba, Joao Ascensao, Rowan Chlebowski, Robert Detrano, Anita Nelson, Michele Geller, Evelyn Whitlock, Patricia Elmer, Victor Stevens, Njeri Karanja, Bette Caan, Stephen Sidney, Geri Bailey, Jane Hirata, Jane Morley Kotchen, Vanessa Barnabei, Theodore A Kotchen, Mary Ann C Gilligan, Joan Neuner, Barbara V Howard, Lucile Adams-Campbell, Lawrence Lessin, Monique Rainford, Gabriel Uwaifo, Linda Van Horn, Philip Greenland, Janardan Khandekar, Kiang Liu, Carol Rosenberg, Henry Black, Lynda Powell, Ellen Mason, Martha Gulati, Marcia L Stefanick, Mark A Hlatky, Bertha Chen, Randall S Stafford, Sally Mackey, Dorothy Lane, Iris Granek, William Lawson, Gabriel San Roman, Catherine Messina, Rebecca Jackson, Randall Harris, Electra Paskett, W Jerry Mysiw, Michael Blumenfeld, Cora E Lewis, Albert Oberman, James M Shikany, Monika Safford, Mona Fouad, Tamsen Bassford, Cyndi Thomson, Marcia Ko, Ana Maria Lopez, Cheryl Ritenbaugh, Jean Wactawski-Wende, Maurizio Trevisan, Ellen Smit, Susan Graham, June Chang, John Robbins, S Yasmeen, F Allan Hubbell, Gail Frank, Nathan Wong, Nancy Greep, Bradley Monk, Howard Judd, David Heber, Robert Elashoff, Robert D Langer, Michael H Criqui, Gregory T Talavera, Cedric F Garland, Matthew A Allison, Margery Gass, Suzanne Wernke, Marian Limacher, Michael Perri, Andrew Kaunitz, R Stan Williams, Yvonne Brinson, J David Curb, Helen Petrovitch, Beatriz Rodriguez, Kamal Masaki, Santosh Sharma, Robert Wallace, James Torner, Susan Johnson, Linda Snetselaar, Jennifer Robinson, Judith Ockene, Milagros Rosal, Ira Ockene, Robert Yood, Patricia Aronson, Norman Lasser, Baljinder Singh, Vera Lasser, John Kostis, Peter McGovern, Mary Jo O'Sullivan, Linda Parker, Timothy DeSantis, Diann Fernandez, Pat Caralis, Karen L Margolis, Richard H Grimm, Mary F Perron, Cynthia Bjerk, Sarah Kempainen, Robert Brunner, William Graettinger, Vicki Oujevolk, Michael Bloch, Gerardo Heiss, Pamela Haines, David Ontjes, Carla Sueta, Ellen Wells, Lewis Kuller, Jane Cauley, N Carole Milas, Karen C Johnson, Suzanne Satterfield, Raymond W Ke, Stephanie Connelly, Fran Tylavsky, Robert Brzyski, Robert Schenken, Jose Trabal, Mercedes Rodriguez-Sifuentes, Charles Mouton, Gloria E Sarto, Douglas Laube, Patrick McBride, Julie Mares-Perlman, Barbara Loevinger, Denise Bonds, Greg Burke, Robin Crouse, Mara Vitolins, Scott Washburn, Susan Hendrix, Michael Simon, Gene McNeeley, John Foreyt, Dallas Hall, Sally McNagny, Nelson Watts, Valery Miller, Robert Hiatt, Barbara Valanis, Carolyn Clifford, Thomas Moon, Frank Meyskens Jr, James Liu, Marianna Baum, Sandra Daugherty, David Sheps, Barbara Hulka, William Applegate, Catherine Allen, Janet Wittes, Eugene Braunwald, Margaret Chesney, Harvey Cohen, Elizabeth Barrett-Connor, David DeMets, Leo Dunn, Johanna Dwyer, Robert P Heaney, Daniel Marson, Victor Vogel, LeRoy Walters, Kristine Yaffe, Salim Yusuf, Anne McTiernan, Jean Wactawski-Wende, LieLing Wu, Rebecca J Rodabough, Nelson B Watts, Frances Tylavsky, Ruth Freeman, Susan Hendrix, Rebecca Jackson, Women's Health Initiative Investigators, Barbara Alving, Jacques Rossouw, Linda Pottern, Shari Ludlam, Joan McGowan, Nancy Geller, Leslie Ford, Ross Prentice, Garnet Anderson, Andrea LaCroix, Ruth Patterson, Anne McTiernan, Barbara Cochrane, Julie Hunt, Lesley Tinker, Charles Kooperberg, Martin McIntosh, C Y Wang, Chu Chen, Deborah Bowen, Alan Kristal, Janet Stanford, Nicole Urban, Noel Weiss, Emily White, Sally Shumaker, Ronald Prineas, Michelle Naughton, Evan Stein, Peter Laskarzewski, Steven R Cummings, Michael Nevitt, Lisa Palermo, Lisa Harnack, Frank Cammarata, Steve Lindenfelser, Bruce Psaty, Susan Heckbert, Sylvia Wassertheil-Smoller, William Frishman, Judith Wylie-Rosett, David Barad, Ruth Freeman, Jennifer Hays, Ronald Young, Jill Anderson, Sandy Lithgow, Paul Bray, JoAnn Manson, J Michael Gaziano, Claudia Chae, Kathryn Rexrode, Caren Solomon, Annlouise R Assaf, Carol Wheeler, Charles Eaton, Michelle Cyr, Lawrence Phillips, Margaret Pedersen, Ora Strickland, Margaret Huber, Vivian Porter, Shirley A A Beresford, Vicky M Taylor, Nancy F Woods, Maureen Henderson, Robyn Andersen, Judith Hsia, Nancy Gaba, Joao Ascensao, Rowan Chlebowski, Robert Detrano, Anita Nelson, Michele Geller, Evelyn Whitlock, Patricia Elmer, Victor Stevens, Njeri Karanja, Bette Caan, Stephen Sidney, Geri Bailey, Jane Hirata, Jane Morley Kotchen, Vanessa Barnabei, Theodore A Kotchen, Mary Ann C Gilligan, Joan Neuner, Barbara V Howard, Lucile Adams-Campbell, Lawrence Lessin, Monique Rainford, Gabriel Uwaifo, Linda Van Horn, Philip Greenland, Janardan Khandekar, Kiang Liu, Carol Rosenberg, Henry Black, Lynda Powell, Ellen Mason, Martha Gulati, Marcia L Stefanick, Mark A Hlatky, Bertha Chen, Randall S Stafford, Sally Mackey, Dorothy Lane, Iris Granek, William Lawson, Gabriel San Roman, Catherine Messina, Rebecca Jackson, Randall Harris, Electra Paskett, W Jerry Mysiw, Michael Blumenfeld, Cora E Lewis, Albert Oberman, James M Shikany, Monika Safford, Mona Fouad, Tamsen Bassford, Cyndi Thomson, Marcia Ko, Ana Maria Lopez, Cheryl Ritenbaugh, Jean Wactawski-Wende, Maurizio Trevisan, Ellen Smit, Susan Graham, June Chang, John Robbins, S Yasmeen, F Allan Hubbell, Gail Frank, Nathan Wong, Nancy Greep, Bradley Monk, Howard Judd, David Heber, Robert Elashoff, Robert D Langer, Michael H Criqui, Gregory T Talavera, Cedric F Garland, Matthew A Allison, Margery Gass, Suzanne Wernke, Marian Limacher, Michael Perri, Andrew Kaunitz, R Stan Williams, Yvonne Brinson, J David Curb, Helen Petrovitch, Beatriz Rodriguez, Kamal Masaki, Santosh Sharma, Robert Wallace, James Torner, Susan Johnson, Linda Snetselaar, Jennifer Robinson, Judith Ockene, Milagros Rosal, Ira Ockene, Robert Yood, Patricia Aronson, Norman Lasser, Baljinder Singh, Vera Lasser, John Kostis, Peter McGovern, Mary Jo O'Sullivan, Linda Parker, Timothy DeSantis, Diann Fernandez, Pat Caralis, Karen L Margolis, Richard H Grimm, Mary F Perron, Cynthia Bjerk, Sarah Kempainen, Robert Brunner, William Graettinger, Vicki Oujevolk, Michael Bloch, Gerardo Heiss, Pamela Haines, David Ontjes, Carla Sueta, Ellen Wells, Lewis Kuller, Jane Cauley, N Carole Milas, Karen C Johnson, Suzanne Satterfield, Raymond W Ke, Stephanie Connelly, Fran Tylavsky, Robert Brzyski, Robert Schenken, Jose Trabal, Mercedes Rodriguez-Sifuentes, Charles Mouton, Gloria E Sarto, Douglas Laube, Patrick McBride, Julie Mares-Perlman, Barbara Loevinger, Denise Bonds, Greg Burke, Robin Crouse, Mara Vitolins, Scott Washburn, Susan Hendrix, Michael Simon, Gene McNeeley, John Foreyt, Dallas Hall, Sally McNagny, Nelson Watts, Valery Miller, Robert Hiatt, Barbara Valanis, Carolyn Clifford, Thomas Moon, Frank Meyskens Jr, James Liu, Marianna Baum, Sandra Daugherty, David Sheps, Barbara Hulka, William Applegate, Catherine Allen, Janet Wittes, Eugene Braunwald, Margaret Chesney, Harvey Cohen, Elizabeth Barrett-Connor, David DeMets, Leo Dunn, Johanna Dwyer, Robert P Heaney, Daniel Marson, Victor Vogel, LeRoy Walters, Kristine Yaffe, Salim Yusuf

Abstract

Background: The effects of dietary changes on osteoporosis, low bone density, and frequent falls are unestablished.

Objective: We assessed the effect of the Women's Health Initiative Dietary Modification low-fat and increased fruit, vegetable, and grain intervention on incident hip, total, and site-specific fractures and self-reported falls, and, in a subset, on bone mineral density (BMD).

Design: Postmenopausal women (n = 48,835) aged 50-79 y (18.6% of minority race-ethnicity) were randomly assigned to receive the Dietary Modification intervention (40%, n = 19,541) (daily goal: < or =20% of energy as fat, > or =5 servings of vegetables and fruit, and > or =6 servings of grains) or to a comparison group that received no dietary changes (60%; n = 29,294).

Results: After a mean 8.1 y of follow-up, 215 women in the intervention group and 285 women in the comparison group (annualized rate: 0.14% and 0.12%, respectively) experienced a hip fracture (hazard ratio: 1.12; 95% CI: 0.94, 1.34; P = 0.21). The intervention group (n = 5423; annualized rate: 3.44%) had a lower rate of reporting > or =2 falls than did the comparison group (n = 8695; annualized rate: 3.67%) (HR: 0.92; 95% CI: 0.89, 0.96; P < 0.01). There was a significant interaction according to hormone therapy use; those in the comparison group receiving hormone therapy had the lowest incidence of hip fracture. In a subset of 3951 women, hip BMD at years 3, 6, and 9 was 0.4-0.5% lower in the intervention group than in the comparison group (P = 0.003).

Conclusions: A low-fat and increased fruit, vegetable, and grain diet intervention modestly reduced the risk of multiple falls and slightly lowered hip BMD but did not change the risk of osteoporotic fractures. This trial was registered at clinicaltrials.gov as NCT00000611.

Figures

FIGURE 1
FIGURE 1
Participant screening and randomization.
FIGURE 2
FIGURE 2
Mean (±SE) percentage changes from baseline in hip bone mineral density (BMD), spine BMD, and total-body BMD in a subset of participants in the Women's Health Initiative Dietary Modification trial from 3 clinical centers who were randomly assigned to the Dietary Modification intervention group (n = 1580) or to a comparison group (n = 2371). Generalized estimating equations were used to compare the mean percentage changes in BMD from baseline by visit, with adjustment for clinical center, race-ethnicity, and weight (kg) at the corresponding visit. Mean (±SD) change in hip BMD from baseline: 0.87 ± 0.14 in the intervention group and 0.88 ± 0.14% in the comparison group. Mean (±SD) change in spine BMD from baseline: 0.99 ± 0.17 in the intervention group and 0.99 ± 0.17% in the comparison group. Mean (±SD) change in total-body BMD from baseline: 1.02 ± 0.11% in the intervention group and 1.03 ± 0.11 in the comparison group.

Source: PubMed

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