STATEMENT of REASONS

REPATRIATION MEDICAL AUTHORITY

STATEMENT of REASONS

RE: INVESTIGATION INTO OSTEOPAENIA

Part I INTRODUCTION 3

Part II Background to the Investigation 3

Part III Submissions received by the Authority pursuant to section 196F 3

Part IV Evidence/Information Available to the Repatriation Medical Authority 3

Part V Disease and injury 4

Part VI Reasons for the decision 5

Part VII Diagnosis of Osteoporosis 6

Part VIII Distribution of bone mineral density 6

Part IX Relationship between BMD and Osteoporosis 7

Part X BMD as a risk factor 7

Part XI Osteopaenia as a risk factor 8

Part XII Decision 8

Part XIII Bibliography 9

Statement of Reasons – Re: Investigation into Osteopaenia Page 3 of 48

Part I  INTRODUCTION

1. The Repatriation Medical Authority (the Authority) has decided not to make Statements of Principles (SoPs) under subsections 196B (2) or (3) of the Veterans’ Entitlements Act 1986 (the Act) in respect of osteopaenia, following notice of an investigation gazetted on 20 July 2005 in the Commonwealth of Australia Gazette.
2. The Authority considers that osteopaenia is not a disease or injury for the purposes of the Veterans’ Entitlements Act 1986 and hence is not a condition for which a Statement of Principles could be formulated.

Part II  Background to the Investigation

1. The Repatriation Medical Authority, under section 196B(4) of the Act, decided to investigate whether a Statement of Principles may be determined in respect of osteopaenia, following a request to carry out an investigation in respect of this condition from a veterans’ organisation.
2. The investigation notice was signed by the Chairman of the Authority on 15 July 2005 and was gazetted in accordance with section 196G of the Act in the Commonwealth of Australia Gazette on 20 July 2005. Submissions were invited from persons and organisations wishing to make a submission by 24 October 2005.
3. Osteoporosis, (but not osteopaenia) has been determined by the Authority to be causal of fractures in the Statements of Principles for fracture.[1]

Part III  Submissions received by the Authority pursuant to section 196F

6.  Following notification of its investigation, the Authority did not receive any information from persons eligible to make submissions pursuant to section 196F.

Part IV  Evidence/Information Available to the Repatriation Medical Authority

1. The following information was available to the Authority.

7.1.  Literature search using Medline, within the parameter of ‘osteoporosis’ as a Medical Subject Heading (MeSH) term. There is no separate MeSH term for osteopaenia, but the osteoporosis literature covers the whole spectrum of reduced bone mineral density and the risk factors for osteoporosis and osteopaenia are the same. The search was limited to human studies, English language publications, and the subheadings of ‘etiology’, ‘epidemiology’, ‘prevention and control’ and ‘chemically induced’. Review articles were selected in the first instance, supplemented by specific searches for osteoporosis and individual factors of interest, as well as hand searches of reference lists

7.2.  Medical or scientific publications as set out in the bibliography attached hereto.

7.3.  Briefing prepared for presentation to the Authority by a medical officer from the Secretariat in conjunction with the Chairman of the Authority.

Part V  Disease and injury

1. Section 5D of the Act defines disease and injury relevantly as follows:

disease means:

(a) any physical or mental ailment, disorder, defect or morbid condition (whether of sudden onset or gradual development); or

(b) the recurrence of such an ailment, disorder, defect or morbid condition;

but does not include:

(c) the aggravation of such an ailment, disorder, defect or morbid condition; or

(d) a temporary departure from:

(i) the normal physiological state; or

(ii) the accepted ranges of physiological or biochemical measures;

that results from normal physiological stress (for example, the effect of exercise on blood pressure) or the temporary effect of extraneous agents (for example, alcohol on blood cholesterol levels);

[and]

injury means any physical or mental injury (including the recurrence of a physical or mental injury) but does not include:

(a) a disease; or

(b) the aggravation of a physical or mental injury.

1. Having regard to the broad definition of ‘disease’ and ‘injury’, the proper meaning of what constitutes a disease or injury for the purposes of determining a Statement of Principles under the Act is to be determined by the Authority. In considering these terms, the Authority had regard to ordinary dictionary definitions, medical dictionaries, and its expert knowledge.
2. The ordinary dictionary definitions of ‘disease’ and ‘ailment’, ‘disorder’, ‘defect’ or ‘morbid condition’ and ‘injury’ such as the following were considered:

A pathological condition of a part, organ, or system of an organism resulting from various causes, such as infection, genetic defect, or environmental stress, and characterised by an identifiable group of signs or symptoms.

A morbid condition of the body, or of some organ or part; illness; sickness; ailment.

11.  There is a circular aspect to both the common definition of ‘disease’ and the common definitions of ‘ailment’, ‘disorder’, ‘morbid condition’. As such, in determining whether a condition is a disease as defined, the Authority is entitled to have regard to the connotations of the word ‘disease’ as used and understood in its ordinary meaning.[2]

1. Accordingly, applying that reasoning to the definition of ‘disease’ in section 5D, the Authority formed the opinion that it would not be enough for a condition to be a ‘defect’ in one or more meanings of that word (or ailment, disorder, or morbid condition) if there was otherwise no connotation of disease in its ordinary usage.
2. Being familiar with the ordinary English meanings of the terms that are used in section 5D, the Authority considered whether osteopaenia was within the ordinary meaning of these terms, and applied the ordinary meaning of those terms to its consideration of whether osteopaenia is a disease. It also relied upon its expert medical knowledge and had regard to the internationally accepted concept of when low bone mass becomes a disease.

14.  Having done so, the Authority considers that osteopaenia is not a disease or injury for the purposes of the Veterans’ Entitlements Act 1986 and is hence not a condition for which a Statement of Principles could be formulated.

Part VI  Reasons for the decision

15.  The Authority had previously determined that osteoporosis can be related to the relevant service.[3]

16.  The WHO internationally accepted definition of osteoporosis is a systemic disease characterised by low bone mass and micro architectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture.[4]

Part VII  Diagnosis of Osteoporosis

17.  The internationally accepted diagnostic tool for osteoporosis is based on a value for bone mineral density below a cut-off threshold. This is akin to the way in which a patient above a cut-off level for blood pressure is diagnosed as hypertensive.[5]

Part VIII  Distribution of bone mineral density

18.  Bone mineral density (BMD) is normally distributed at all ages (Figure 1). Within this distribution, individual bone density values are expressed in relation to a reference population in standard deviation (SD) units. Standard deviation units used in relation to the young healthy adult population are called T-scores.

Figure 1 Distribution of BMD in healthy women aged 30-40 years

Source: WHO 2003

19.  The World Health Organisation (WHO) has defined the points on the curve at which a person is defined as having osteopaenia or osteoporosis, based on measurements by dual-energy X-ray absorptiometry, as follows: [6]

Normal: A value of BMD within 1 standard deviation of the young adult reference mean (T-score ≥-1).

Low bone mass (osteopaenia): A value of BMD more than 1 standard deviation below the young adult mean, but less than 2.5 standard deviations below this value
(T-score < -1 and -2.5).

Osteoporosis: A value of BMD 2.5 standard deviations or more below the young adult mean (T-score ≤ - 2.5).

Severe osteoporosis (established osteoporosis). A value of BMD 2.5 standard deviations or more below the young adult mean, in the presence of one or more fragility fractures.

20.  Estimates of the prevalence of osteoporosis within the Australian population vary between 300,000 in 2001 and 1.8 million in 1995, depending on the source of data.[7] The proportion of people with osteoporosis increases approximately exponentially with age.

Part IX  Relationship between BMD and Osteoporosis

21.  Although the diagnosis of osteoporosis is based on a value for BMD below a cut-off threshold, there is no absolute threshold of BMD that discriminates absolutely from those who will, or will not, have a fracture. Prospective studies have shown, however, that the risk of fracture in general increases progressively the lower the BMD, regardless of measurement site. The risk of hip fracture in men is similar to that in women for the same BMD, and increases 2.6 fold (95% CI 2.0-3.5) for each SD decrease in BMD.[8] The risk of spine fracture increases 1.5 to 2 fold for a one SD decreases in BMD or a 10% decrease in T score.[9] The ability of BMD to predict hip fractures is better or at least as good as that of the measurement of blood pressure to predict stroke.

Part X  BMD as a risk factor

1. However, BMD is not the only risk factor for fractures; low bone density predicts about half the risk for fragility fractures.[10] Other risk factors for fracture include propensity to fall, poor bone quality and numerous clinical risk factors. Some of these risk factors operate independently of BMD. For example, maternal family history, previous fragility fractures or low body mass are risk factors even when adjusted for BMD.[11]

Part XI  Osteopaenia as a risk factor

1. Osteopaenia is a risk factor for fractures. Low bone mass is of itself not suggestive of a morbid condition or disease.
2. While it may be thought that low bone mass satisfies the broader definition of ‘disease’ and is not a temporary departure from a normal physiological state it is not characterised by any identifiable group of signs or symptoms.

25.  Evidence-based practice guidelines suggest that men and women with BMD values 2.5 standard deviations or more below the average for the young healthy female population should be offered appropriate intervention. Assessment of fracture risk is also related to the presence of other clinical risk factors. Intervention may be considered for individuals with osteopaenia who have strong risk factors that increase their risk of fracture, taking into consideration the risks and benefits of the proposed treatment, but it is not of itself a disease requiring intervention.

1. This can be contrasted with osteoporosis, where the degree of bone loss is such that the risk of fracture is high, and treatment to reduce fracture risk is recommended.

Part XII  Decision

1. At its meeting on 11 April 2006 the Authority decided not to make a Statement of Principles in respect of osteopaenia for the purposes of subsection (2) or (3) of section 196B of the Act as the Authority concluded, for the reasons set out above, that it is not a disease within the meaning of section 5D of the Act.

Part XIII  Bibliography

RMA ID Number / Article Reference
38015 / Abraham G, Halbreich U, Freidman RH, Josiassen RC (2002). Bone mineral density and prolactin associations in patients with chronic schizophrenia. Schizophrenia Research, 59(1) pp 17-18.
1075 / Abraham GE and Grewal H (1990) A total dietary program emphsizing magnesium instead of calcium. Effect on the mineral density of calcaneous bone in postmenopausal women on hormonal therapy. Journal of reproductive medicine. Vol 35 No 5 pp 503-507.
38013 / Abrahamsen Bo, Andersen I, Christensen SS, Madsen JS, Brixen K. (2005) Utility of testing for monoclonal bands in serum of patients with suspected osteoporosis: retrospective, cross sectional study. BMJ Vol 330 pp 818-20.
9758 / Adachi JD (1997). Corticosteroid-induced osteoporosis. The American Journal of the Medical Sciences. Vol 313(1) pp 41-49.
37317 / Adams JE (2002). Dialysis bone disease. Seminars in Dialysis, Vol 15 (4) pp 277-89.
38062 / Adler G (2005). Cushing Syndrome. Obtained from http://emedicine.com/EMERG/topic117.htm
38003 / Adler RA, Funkhouser HL, Petkov VI, Berger MM (2003). Glucocorticoid-induced osteoporosis in patients with sarcoidosis. American Journal of the Medical Sciences, 325(1) pp 1-6.
38229 / Afandi B, Toumeh MS, Saadi HF (2003). Cushing's Syndrome caused by unsupervised use of ocular glucocorticoids. Endocrine Practice, 9(6) pp 526-529.
23941 / Affinito P, Sorrentino C, Farace MJ, di Carlo C, Moccia G, Canciello P, Palomba S and Nappi C (1996). Effects of thyroxine therapy on bone metabolism in postmenopausal women with hypothyroidism. Acta Obstetricia et Gynecologica Scandinavica, Vol 75 pp 843-848.
9754 / Affinito P; Sorrentino C; Farace M; De Carlo C; Gianfranco M; Canciello P; Palomba S & Nappi C (1996). Effects of thyroxine therapy on bone metabolism in postmenopausal women with hypothyroidism. Acta Obstet Gynecol Scand (75) pp 843-848.
38301 / Agarwal SK (2002). Impact of six months of GnRH agonist therapy for endometriosis. Jnl Reproductive Medicine, 47(7) pp 530-534.
38325 / Agency for Toxic Substances and Disease Registry (2005). DRAFT - Toxicological Profile for Lead. US Department of Health and Human Services, Public Health Service.
38327 / Agency for Toxic Substances and Disease Registry (2005). Toxicological Profile for Zinc. US Department of Health and Human Services, Public Health Service.
1076 / Agre JC (1993) Risk of osteoporosis in women: importance of distinguishing between physical activity and aerobic capacity. Mayo Clin Proc. Vol 68 pp 821-822.
37407 / Albrand G, Munoz F, Sornay-Rendu E, DuBoeuf F, & Delmas PD. (2003) Independent predictors of all osteoporosis-related fractures in healthy postmenopausal women: The OFELY Study. Bone Vol 32 pp 78-85.
23140 / Alekel DL, Mortillaro E, Hussain EA, West B, Ahmed N, Peterson CT, Werner RK, Arjmandi BH, & Kukreja SC. (1999). Lifestyle and biologic contributors to proximal femur bone mineral density and hip axis length in two distinct ethnic groups of premonopausal women. Osteoporosis International, Vol 9 pp 327-338.
37315 / Alesci S, De Martino MU, Ilias I, Gold PW, Chrousos GP (2005). Glucocorticoid-induced osteoporosis: from basic mechanisms to clinical aspects. Neuroimmunomodulation, Vol 12 pp 1-19.
37396 / Alfven T, Elinder C-G, Dea Carlsson M, Grubb A, Hellstrom L, Persson B, Pettersson C, Spang G, Schutz A, & Jarup L. (2000) Low-level cadmium exposure and osteoporosis. J Bone Miner Res Vol 15(8) pp 1579-86.