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Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00054418
Collaborator
National Cancer Institute (NCI) (NIH)
216
Enrollment
199
Locations
2
Arms
62
Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss.

PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: calcium carbonate
  • Dietary Supplement: vitamin D
  • Drug: risedronate sodium
  • Other: placebo
 Phase 3

Detailed Description

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to planned tamoxifen therapy (yes vs no vs undecided), planned taxane therapy (yes vs no vs undecided), time from last menses (1-3 months vs longer than 3 months to 6 months), and age (under 40 vs 40 to 49 vs 50 and over). Patients are randomized to 1 of 2 treatment arms. In both arms, treatment begins during the first month of chemotherapy and continues for 1 year in the absence of unacceptable toxicity. For more information regarding the treatment arms, please see the "Arms" section below. Questionnaires about cessation of menses, ovarian failure, and menopausal symptoms are completed at baseline, monthly during chemotherapy, at 6 months, and then at 1 and 2 years.

Patients are followed for 1 year. A summary of study goals is listed below.

Goals:

  1. To evaluate the effectiveness of risedronate at a weekly oral dose of 35 mg versus placebo in the prevention of bone loss in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.

  2. To evaluate the degree of bone loss over one year in premenopausal women undergoing adjuvant chemotherapy for primary breast cancer according to menopausal status at one year after therapy begins.

  3. To evaluate the relationship of current climacteric symptoms, menstrual and reproductive history, and chemotherapy regimen with ovarian failure (permanent cessation of menses) in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.

  4. To evaluate the relationship of baseline serum estradiol levels with ovarian failure in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.

Study Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
A Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of Risedronate (Actonel) For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma
Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: calcium carbonate, vitamin D and risedronate

Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.

Dietary Supplement: calcium carbonate
calcium 600 mg daily administered orally for one year

Dietary Supplement: vitamin D
vitamin D 400 U daily administered orally for one year

Drug: risedronate sodium
risedronate 35 mg weekly administered orally
Placebo Comparator: calcium carbonate, vitamin D and placebo

Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly.

Dietary Supplement: calcium carbonate
calcium 600 mg daily administered orally for one year

Dietary Supplement: vitamin D
vitamin D 400 U daily administered orally for one year

Other: placebo
placebo tablet weekly administered orally for one year

Outcome Measures

Primary Outcome Measures

  1. Average intra-patient change in lumbar spine (L2-L4, PA) bone mineral density (BMD) from baseline to one year after study entry [1 year post study entry]

Secondary Outcome Measures

  1. Average intra-patient change in femoral neck and total hip BMD from baseline to one year after study entry [1 year post study entry]

  2. Incidence of osteopenia in the risedronate vs placebo groups at one year after study entry [1 year post study entry]

  3. Incidence of osteoporosis in the risedronate vs placebo groups at one year after study entry [1 year post study entry]

  4. Incidence of a 5% difference in intra-patient BMD scores at baseline [Baseline]

  5. Serum and urine N-telopeptide and serum alkaline phosphatase at baseline and 6 months [Up to 6 months]

  6. Frequency and severity of toxicity as measured by NCI CTC version 2.0 [Up to 1 year post study treatment]

  7. Menopausal symptoms as measured by the Greene Climacteric Scale (GCS) at baseline, monthly during chemotherapy, at 6 months, 1 year, and 2 years after study entry [Up to 2 years post study entry]

  8. Association of baseline serum estradiol levels with permanent cessation of menses [Baseline]

  9. Relationship between the subscales of the GCS (psychological, vasomotor, somatic and sexual) with type of chemotherapy, duration of chemotherapy, and menstrual cycle changes [Up to 2 years post study entry]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

  1. Required Characteristics

  2. Premenopausal women

  • ≤ 6 months since last menstrual period

  • no prior bilateral oophorectomy

  • not on estrogen replacement therapy

  • if TAH is performed, with at least one intact ovary, or if > 3 months since last menstrual period, then patients must have premenopausal estrogen levels ≤ 1 month of study entry

  1. Scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages I-IIIB)

  2. ≥ 18 years of age

  3. ECOG performance status (PS) 0 or 1

  4. Contraindications

  5. Hypercalcemia (calcium level > 1mg/dL above UNL ≤ 6 months

  6. Hypocalcemia (calcium level > 0.5 mg/dL below UNL ≤ 6 months

  7. Inability to stand or sit upright for at least 30 minutes

  8. Known swallowing disorder

  9. Bone mineral density T score of ≤ - 2.0 at the hip or lumbar spine

  • a patient with a T score of - 2.1 is ineligible

  • a patient with a T score of - 1.9 is eligible

  1. History of vertebral compression fracture
  • Exception: traumatic fracture of the coccyx would not exclude a patient from participation

  1. Corticosteroids at doses > 5 mg daily of prednison or equivalent for > 2 weeks in the past 6 months

  2. Previous treatment with bisphosphonates

  3. Diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism)

  4. History of severe renal impairment or creatinine > 2.0 mg/dL

  5. Malabsorption syndrome

  6. Estrogen replacement therapy

  7. Oral contraceptive use

  8. Prior bilateral oophorectomy

  9. Pregnant women

  • Nursing women

  • Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, injections, intrauterine device [IUD], surgical sterilization, abstinence, etc.)

  • This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown

  1. Dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mobile Infirmary Medical Center Mobile Alabama United States 36652-2144
2 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259
3 Aurora Presbyterian Hospital Aurora Colorado United States 80012
4 Boulder Community Hospital Boulder Colorado United States 80301-9019
5 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
6 Porter Adventist Hospital Denver Colorado United States 80210
7 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
8 St. Joseph Hospital Denver Colorado United States 80218
9 Rose Medical Center Denver Colorado United States 80220
10 CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado United States 80224-2522
11 Swedish Medical Center Englewood Colorado United States 80110
12 Sky Ridge Medical Center Lone Tree Colorado United States 80124
13 Hope Cancer Care Center at Longmont United Hospital Longmont Colorado United States 80502
14 St. Mary-Corwin Regional Medical Center Pueblo Colorado United States 81004
15 North Suburban Medical Center Thorton Colorado United States 80229
16 Gainesville Florida United States 32605
17 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
18 Piedmont Hospital Atlanta Georgia United States 30309
19 Northside Hospital Cancer Center Atlanta Georgia United States 30342-1611
20 Saint Joseph's Hospital of Atlanta Atlanta Georgia United States 30342-1701
21 CCOP - Atlanta Regional Atlanta Georgia United States 30342
22 MBCCOP-Medical College of Georgia Cancer Center Augusta Georgia United States 30912
23 WellStar Cobb Hospital Austell Georgia United States 30106
24 Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur Georgia United States 30033
25 Gwinnett Medical Center Lawrenceville Georgia United States 30045
26 Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta Georgia United States 30060
27 Southern Regional Medical Center Riverdale Georgia United States 30274-2600
28 Rush-Copley Cancer Care Center Aurora Illinois United States 60507
29 St. Joseph Medical Center Bloomington Illinois United States 61701
30 Graham Hospital Canton Illinois United States 61520
31 Memorial Hospital Carthage Illinois United States 62321
32 Eureka Community Hospital Eureka Illinois United States 61530
33 Galesburg Clinic Galesburg Illinois United States 61401
34 Galesburg Cottage Hospital Galesburg Illinois United States 61401
35 InterCommunity Cancer Center of Western Illinois Galesburg Illinois United States 61401
36 Mason District Hospital Havana Illinois United States 62644
37 Hopedale Medical Complex Hopedale Illinois United States 61747
38 Joliet Oncology Hematology Associates, Limited - West Joliet Illinois United States 60435
39 Kewanee Hospital Kewanee Illinois United States 61443
40 McDonough District Hospital Macomb Illinois United States 61455
41 Trinity Medical Center - East Moline Illinois United States 61265
42 Moline Illinois United States 61265
43 BroMenn Regional Medical Center Normal Illinois United States 61761
44 Community Cancer Center Normal Illinois United States 61761
45 Community Hospital of Ottawa Ottawa Illinois United States 61350
46 Oncology Hematology Associates of Central Illinois - Ottawa Ottawa Illinois United States 61350
47 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
48 Proctor Hospital Peoria Illinois United States 61614
49 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
50 Oncology/Hematology Associates of Central Illinois, P.C. Peoria Illinois United States 61615
51 Methodist Medical Center of Illinois Peoria Illinois United States 61636
52 OSF St. Francis Medical Center Peoria Illinois United States 61637
53 Illinois Valley Community Hospital Peru Illinois United States 61354
54 Perry Memorial Hospital Princeton Illinois United States 61356
55 St. Margaret's Hospital Spring Valley Illinois United States 61362
56 Valley Cancer Center Spring Valley Illinois United States 61362
57 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
58 CCOP - Carle Cancer Center Urbana Illinois United States 61801
59 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
60 McFarland Clinic, P. C. Ames Iowa United States 50010
61 Bettendorf Iowa United States 52722
62 Saint Anthony Regional Hospital Carroll Iowa United States 51401
63 St. Luke's Hospital Cedar Rapids Iowa United States 52402
64 Cedar Rapids Oncology Associates Cedar Rapids Iowa United States 52403
65 Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa United States 52403
66 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
67 Mercy Capitol Hospital Des Moines Iowa United States 50307
68 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
69 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
70 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
71 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
72 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
73 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316-2301
74 Alegent Health Community Memorial Hospital Missouri Valley Iowa United States 51555-1199
75 Burgess Health Center Onawa Iowa United States 51040
76 Ottumwa Regional Health Center Cancer Center Ottumwa Iowa United States 52501
77 Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center Sioux City Iowa United States 51101
78 Siouxland Regional Cancer Center Sioux City Iowa United States 51101
79 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
80 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
81 Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa United States 50266
82 Cancer Center of Kansas, P.A. - Chanute Chanute Kansas United States 66720
83 Cancer Center of Kansas, P.A. - Dodge City Dodge City Kansas United States 67801
84 Cancer Center of Kansas, P.A. - El Dorado El Dorado Kansas United States 67042
85 Cancer Center of Kansas, P.A. - Kingman Kingman Kansas United States 67068
86 Southwest Medical Center Liberal Kansas United States 67901
87 Cancer Center of Kansas, P.A. - Newton Newton Kansas United States 67114
88 Cancer Center of Kansas, P.A. - Parsons Parsons Kansas United States 67357
89 Cancer Center of Kansas, P.A. - Pratt Pratt Kansas United States 67124
90 Cancer Center of Kansas, P.A. - Salina Salina Kansas United States 67042
91 Cancer Center of Kansas, P.A. - Wellington Wellington Kansas United States 67152
92 Associates in Womens Health, P.A. - North Review Wichita Kansas United States 67203
93 Cancer Center of Kansas, P.A. - Medical Arts Tower Wichita Kansas United States 67208
94 Cancer Center of Kansas, P.A. - Wichita Wichita Kansas United States 67214
95 CCOP - Wichita Wichita Kansas United States 67214
96 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
97 Cancer Center of Kansas, P.A. - Winfield Winfield Kansas United States 67156
98 Ochsner Clinic of Baton Rouge Baton Rouge Louisiana United States 708169990
99 Terrebonne General Medical Center Houma Louisiana United States 70360
100 CCOP - Ochsner New Orleans Louisiana United States 70121
101 Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana United States 70121
102 Hickman Cancer Center at Bixby Medical Center Adrian Michigan United States 49221
103 St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital Ann Arbor Michigan United States 48106-0995
104 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
105 Green Bay Oncology, Limited - Escanaba Escanaba Michigan United States 49431
106 Green Bay Oncology, Limited - Iron Mountain Iron Mountain Michigan United States 49801
107 Haematology-Oncology Associates of Ohio and Michigan, P.C. Lambertville Michigan United States 48144
108 Community Cancer Center of Monroe Monroe Michigan United States 48162
109 Mercy Memorial Hospital System Monroe Michigan United States 48162
110 MeritCare Clinic - Bemidji Bemidji Minnesota United States 56601
111 Fairview Ridges Hospital Burnsville Minnesota United States 55337
112 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
113 CCOP - Duluth Duluth Minnesota United States 55805
114 Miller-Dwan Medical Center Duluth Minnesota United States 55805
115 St. Mary's - Duluth Clinic Cancer Center Duluth Minnesota United States 55805
116 Fairview Southdale Hospital Edina Minnesota United States 55435
117 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
118 Immanuel St. Joseph's Clinic Mankato Minnesota United States 56002
119 Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
120 Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale Minnesota United States 55422-2900
121 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
122 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
123 Park Nicollet Health Services St. Louis Park Minnesota United States 55416
124 United Hospital St. Paul Minnesota United States 55102
125 Ridgeview Medical Center Waconia Minnesota United States 55387
126 Hattiesburg Clinic, P.A. Hattiesburg Mississippi United States 39401
127 CCOP - Montana Cancer Consortium Billings Montana United States 59101
128 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59101
129 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
130 St. Vincent Healthcare Billings Montana United States 59101
131 Deaconess Billings Clinic Cancer Center Billings Montana United States 59107-5100
132 Deaconess Billings Clinic - Downtown Billings Montana United States 59107-7000
133 Bozeman Deaconess Hospital Bozeman Montana United States 59715
134 Internal Medicine Associates of Bozeman Bozeman Montana United States 59715
135 St. James Community Hospital Butte Montana United States 59701
136 Great Falls Clinic Great Falls Montana United States 59405
137 St. Peter's Hospital Helena Montana United States 59601
138 Glacier Oncology, PLLC Kalispell Montana United States 59901
139 Kalispell Medical Oncology Kalispell Montana United States 59901
140 Eastern Montana Cancer Center Miles City Montana United States 59301
141 Community Medical Center Missoula Montana United States 59801
142 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
143 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
144 Bryan LGH Medical Center West Lincoln Nebraska United States 68502
145 Cancer Resource Center - Lincoln Lincoln Nebraska United States 68510
146 St. Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
147 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
148 Immanuel Medical Center Omaha Nebraska United States 68122
149 Bergan Mercy Medical Center Omaha Nebraska United States 68124
150 Creighton University Medical Center Omaha Nebraska United States 68131-2197
151 Midlands Cancer Center at Midlands Community Hospital Papillion Nebraska United States 68046-4194
152 Rutherford Hospital Rutherfordton North Carolina United States 28139
153 Bismarck Cancer Center Bismarck North Dakota United States 58501
154 Cancer Care Center at Medcenter One Hospital Bismarck North Dakota United States 58501
155 Mid Dakota Clinic, P. C. Bismarck North Dakota United States 58501
156 St. Alexius Medical Center Bismarck North Dakota United States 58502
157 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
158 MeritCare Medical Group Fargo North Dakota United States 58122
159 Altru Cancer Center at Altru Hospital Grand Forks North Dakota United States 58201
160 Wood County Oncology Center Bowling Green Ohio United States 43402
161 Blanchard Valley Medical Associates Findlay Ohio United States 45840
162 Fremont Memorial Hospital Fremont Ohio United States 43420
163 Kenton Oncology, Incorporated Kenton Ohio United States 43326
164 Lima Memorial Hospital Lima Ohio United States 45804
165 Northwest Ohio Oncology Center Maumee Ohio United States 43537
166 St. Luke's Hospital Maumee Ohio United States 43537
167 St. Charles Mercy Hospital Oregon Ohio United States 43616
168 Toledo Clinic - Oregon Oregon Ohio United States 43616
169 Firelands Regional Medical Center Sandusky Ohio United States 44870
170 North Coast Cancer Care, Incorporated Sandusky Ohio United States 44870
171 Promedica Cancer Center at Flower Hospital Sylvania Ohio United States 43560
172 Mercy Hospital of Tiffin Tiffin Ohio United States 44883
173 Toledo Hospital Toledo Ohio United States 43606
174 St. Vincent Mercy Medical Center Toledo Ohio United States 43608
175 Medical College of Ohio Cancer Institute Toledo Ohio United States 43614
176 CCOP - Toledo Community Hospital Toledo Ohio United States 43623
177 Toledo Clinic, Incorporated - Main Clinic Toledo Ohio United States 43623
178 Toledo Surgical Specialists Toledo Ohio United States 43623
179 Fulton County Health Center Wauseon Ohio United States 43567
180 Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma United States 74136
181 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania United States 18105
182 Geisinger Medical Center Danville Pennsylvania United States 17822-0001
183 Geisinger Medical Group State College Pennsylvania United States 16801
184 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania United States 18711
185 Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson South Carolina United States 29621
186 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
187 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
188 Rapid City Regional Hospital Rapid City South Dakota United States 57701
189 Avera McKennan Hospital and University Health Center Sioux Falls South Dakota United States 57105-1080
190 Medical X-Ray Center, P. C. Sioux Falls South Dakota United States 57105
191 Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota United States 57117-5039
192 Green Bay Oncology, Limited at St. Vincent Hospital Green Bay Wisconsin United States 54301-3526
193 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
194 St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin United States 54303
195 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
196 Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin United States 54154
197 Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235
198 Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming United States 82801
199 Allan Blair Cancer Centre at Pasqua Hospital Regina Saskatchewan Canada S4T 7T1

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Stephanie Hines, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00054418
Other Study ID Numbers:
  • NCCTG-N02C1
  • NCI-2012-02515
  • CDR0000270449
First Posted:
Feb 6, 2003
Last Update Posted:
Jul 13, 2016
Last Verified:
Jul 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
osteoporosis
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Vitamin D
Risedronic Acid
Calcium Carbonate
Calcium

Study Results

No Results Posted as of Jul 13, 2016